Recruiting studies


We are a research active Trust taking part in a variety of research studies across a variety of disease areas.

Please click on the “disease area” below to view the studies that are currently open to recruitment at University Hospitals of Derby and Burton NHS Foundation Trust. You can read more information about each study by searching using the study title in the UK Clinical Trials Gateway Search Tool.

If you are interested in taking part in one of these studies please speak to your doctor, nurse or health care professional. 

Anaesthesia, Perioperative Medicine and Pain Management

Current recruiting studies:
 

Preemptive paracetamol for postoperative pain

NIHR Porfiolio Study ID: 20127

Paracetamol is used commonly to treat pain, including pain after surgery. However, it is not clear when the best time to give it is. Most doctors give this at the end of surgery. Although some studies have suggested paracetamol works better to reduce pain if given before the surgeon cuts the skin. We would like to investigate this with a study.

Perioperative Quality Improvement Programme: Patient Study

NIHR Porfiolio Study ID: 32256

This application is to gather and analyse patient data using the PQIP Database.

PQIP will measure complications after major planned surgery and seek to improve these outcomes through feedback of data to clinicians. A REC/CAG application for the PQIP Database has already received a favourable opinion. This analysis will answer important research questions about variation in quality of care in major surgery. 

We expect that this substantial collaborative work will lead to valuable insights regarding the ways in which hospitals use data to drive improvements in care.

FLO-ELA

NIHR Porfiolio Study ID: 33869

We aim to trial a treatment used to guide the dose and timing of fluid administered into the bloodstream to patients during and shortly after surgery. We will trial this treatment, called “goal-directed haemodynamic therapy” (GDHT), in patients undergoing emergency bowel surgery (laparotomy).

We aim to determine whether GDHT given to patients aged 50+ during and for up to six hours after emergency laparotomy reduces the number of deaths within 90 days of surgery.

 

Blood

Current recruiting studies

UK Childhood ITP Registry

NIHR Porfolio Study ID: 14145

Project website: http://www.uk-itp.org/docs.htm 

This is a registry for children with acute and chronic immune thrombocytopenia (ITP). The primary aim is to relate the long term consequences of a low platelet count to the frequency and severity of bleeding symptoms, and to the requirement for treatment. The study includes an optional quality of life survey.

UKAITPR

NIHR Porfolio Study ID: 4961

The UK Adult ITP Registry aims to collect clinical data (co-morbid conditions, ITP-specific treatments, laboratory results, and bleeding events) and biological samples (whole blood [15 mL, ~EDTA] or saliva [Oragene saliva kit])on adult patients with primary immune thrombocytopenia (ITP) in an effort to investigate outstanding questions in disease progression, treatment effectiveness, and co-morbid burden.

An overview of our study protocol may be found in the document “UKITP Study Protocol 2.1” on the Adult Registry page of our website www.ukitpregistry.com

 

Cancer

Current recruiting studies

Interlace

NIHR Porfiolio Study ID: 11775

To investigate in a randomised trial whether additional short-course chemotherapy given on a weekly schedule immediately before standard chemoradiation leads to an improvement in overall survival in patients with locally advanced cervical cancer.

NSCCG

NIHR Porfiolio Study ID: 1269

Project website: www.icr.ac.uk/nsccg

The purpose of the National Study of Colorectal Cancer Genetics is to collect information from individuals who have been diagnosed with colorectal cancer who also have a family history of the condition, so that we can try and identify new hereditary factors (genes) that may lead to the development of colorectal cancer and further increase our understanding of why this condition develops and perhaps provide new targets for chemotherapy.

OPTIMA

NIHR Porfiolio Study ID: 12255

The OPTIMA trial seeks to advance the development of personalised medicine in breast cancer by using multi-parameter tests to identify those women who are likely to benefit from chemotherapy and sparing those who are unlikely to benefit from an unnecessary and unpleasant treatment. 

The OPTIMA study population would ordinarily be treated with a combination of chemotherapy and endocrine therapy. The trial compares the management of patients using test-directed assignment to chemotherapy with standard management (chemotherapy) in a non-inferiority design. OPTIMA prelim is the preliminary phase of the study which will select the testing technology to be used in the main trial and demonstrate whether the main trial is feasible.

SEARCH: Endometrial cancer

NIHR Porfiolio Study ID: 1390

Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with endometrial cancer.

SEARCH: Ovarian cancer

NIHR Porfiolio Study ID: 1390

A population based study of genetic predisposition and gene environment interactions in Ovarian cancer.

STAMPEDE

NIHR Porfolio Study ID: 1409

Project website: http://stampedetrial.org/

There are increasing numbers of treatments available for advanced prostate cancer. These treatments are usually used in prostate cancer when hormone treatment is no longer effective and the cancer has started to grow again. The aim of this trial, which is called STAMPEDE, is to assess some of these treatments, given earlier in the course of the disease in combination with hormone treatment.

The treatments currently assessed in the trial are:

  • Radiotherapy to the prostate
  • Abiraterone and enzalutamide combination

FOCUS 4

NIHR Porfolio Study ID: 14893

FOCUS4 is an umbrella, or platform, for testing novel agents in biomarker-defined subpopulations of first-line advanced disease colorectal cancer patients who are not considered candidates for potentially curative surgery. It is also a trial of a new strategy for testing stratified approaches to therapy in any biologically complex tumour type.

The backbone of the platform is 16 weeks of treatment with any standard first line colorectal cancer treatment, after which, as is frequently standard practice in the UK and Europe, there is a programmed treatment break for responding and stable patients. During that break, either new agent(s) or placebo is administered. The primary outcome measure for assessing the activity of the new treatment is progression free survival in the interval (time to death or progression requiring resumption of chemotherapy).

MARS 2

NIHR Porfolio Study ID: 15909

Mesothelioma is a cancer of the thin membrane that lines the chest. Around 2500 people in the UK are diagnosed with mesothelioma each year. Exposure to asbestos is the most common cause, although the cancer does not usually become apparent until 40-60 years after exposure.

Anti-cancer drugs (chemotherapy) are usually given to help treat mesothelioma and sometimes lung-sparing surgery (pleurectomy decortication) is undertaken. However, it is not known if this surgery, in addition to chemotherapy, can increase survival and improve the quality of life for patients.

The aim of this study (MARS 2) study is to compare combining this surgery and chemotherapy with chemotherapy alone with respect to overall survival, cost-effectiveness and quality of life at regular intervals for 2 years.

AML18

NIHR Porfolio Study ID: 15938

This trial is primarily designed for patients over the age of 60 who are considered fit enough for an intensive chemotherapy approach and will aim to test the effects of adding new treatment agents to commonly used chemotherapy combinations in order to improve patient survival and treatment regimes.

The AML18 Trial is available to any patient who has primary or secondary AML as defined by the WHO Classification (excluding Acute Promyelocytic Leukaemia), or high risk Myelodysplastic Syndrome (i.e. >10% marrow blasts) over the age of 60.

POSNOC

NIHR Porfolio Study ID: 16069

Project website: http://www.posnoc.co.uk/

The aim of this trial is to assess whether adjuvant therapy alone is not worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years, for women with early stage breast cancer and one or two nodes with macrometastases. Patients will be randomised to adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy.

FLAIR

NIHR Porfolio Study ID: 16675

This is a phase III, multicentre, randomised, controlled, open, parallel group trial in patients with previously untreated chronic lymphocytic leukaemia (CLL). The trial aims to compare the effect on progression-free survival (PFS) of ibrutinib plus rituximab (IR) with that of fludarabine, cyclophosphamide and rituximab (FCR) in patients with previously untreated chronic lymphocytic leukaemia.

An aditiona aim is the comparison of PFS between ibrutinib plus venetoclax (I+V) and ibrutinib alone (I) with FCR, and a comparison of minimal residual disease (MRD) negativity rates in I+V with those in IR or I as appropriate.

LORIS

NIHR Porfolio Study ID: 16736

The LORIS Trial aims to establish whether patients with newly diagnosed low risk ductal carcinoma in situ (DCIS) can safely avoid surgery without detriment to their wellbeing (psychological and physical) and whether those patients who do require surgery can be identified by pathological and radiological means.

LORIS is a phase III, multicentre, 2 arm study, with a built in 2 year feasibility phase, in women confirmed by Central Histopathology Review to have low risk DCIS. Patients will be randomised between standard surgery and active monitoring with annual mammography.

SERRENADE

NIHR Porfolio Study ID: 17059

Patients diagnosed with colorectal cancer routinely undergo a CT scan to identify whether the cancer has spread to other parts of the body, but diagnosis of secondary cancer in the liver is difficult using conventional CT. MRI is known to be better than CT at diagnosing cancer in the liver but it takes a long time to do. Recently it has been suggested that limited MRI of the liver can identify most cancer in the liver, however this has not yet been proven to be effective in patients with a new diagnosis of colorectal cancer. The purpose of this study is to test whether a quick MRI scan of the liver at the time colorectal cancer is diagnosed can identify more cancer that has spread to the liver than conventional CT.

All patients who have been diagnosed with a high risk type of colorectal cancer but no liver metastases on CT will be eligible to take part in the study.

PATCH

NIHR Porfolio Study ID: 1723

Project website: http://www.ctu.mrc.ac.uk/

Prostate Adenocarcinoma: TransCutaneous Hormones. A randomised-controlled trial of transcutaneous oestrogen patches versus LHRH analogues in prostate cancer.

MEASURES

NIHR Porfolio Study ID: 17232

The MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURES) Trial: Serial Assessment of Symptomatic Response to Non Experimental Medical Therapies and/or Phlebotomy in Patients with Myeloproliferative Neoplasms. This study aims to test the diary to see if it is effective at recording the impact of patients symptoms.

MaPLe: Molecular profiling for lymphoma

NIHR Porfolio Study ID: 17628

This study is being set up in order to permit prospective molecular typing of samples of non Hodgkin lymphoma from surplus material obtained at routine biopsies.   It is intended to facilitate identification of patients for whom molecular targeted therapies may be available. The results of molecular typing will be returned to the clinical team caring for the patient, in order to make them aware of specific abnormalities which would make specific targeted therapy an option within a clinical trial.

MCL Biobank Observational Study

NIHR Porfolio Study ID: 17767

Mantle Cell Lymphoma (MCL) is a type of non-Hodgkin's lymphoma; a cancer of the lymphocytes (white blood cells) that occurs when the growth of these cells is out of control. There are currently no tests that can tell us which patients have indolent behaving disease at diagnosis. Knowing this will be really helpful in finding the best way to treat people with this disease in the future. The only way that we can really be sure which type of MCL a patient has, is to observe what happens to them over the next few years. 

We will collect baseline blood and saliva samples, diagnostic biopsy material and clinical information from patients who are newly diagnosed with MCL. These samples will be stored in a Biobank. After this, patients will not directly be involved as the information we need to collect can be found in the medical notes.

Add-Aspirin Trial

NIHR Porfolio Study ID: 18067

A phase III, double blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.

AML19

NIHR Porfolio Study ID: 18218

The AML19 trial looks to build upon previous trials in acute myeloid leukaemia (AML). It is known that the condition can present with one of two subtypes, and this is taken into account in the trial design. 

In the majority of patients (those who do not have the APL-subtype), the trial looks to refine the current standard of care (which is a combination of drugs called DA) by asking a number of questions. In patients with the APL subtype we will continue to assess the real-world effectiveness of standard of care, which is a combination of drugs called AIDA (ATRA plus Idarubicin), and to allow patients to access residual disease monitoring.

PLATFORM

NIHR Porfolio Study ID: 18432

This is a prospective, open label, multicentre, randomised phase II clinical trial which aims to evaluate the efficacy of maintenance therapies following completion of standard first-line chemotherapy in patients with locally advanced or metastatic HER-2 positive or HER-2 negative oesophago-gastric adenocarcinomas.

FOAM Trail

NIHR Porfolio Study ID: 18588

FOAM is a phase III, doubleblind, placebo controlled, randomised controlled trial designed to determine whether folic acid supplementation imporves the frequency and severity of hot flushes in postmenopausal women, either healthy women or breast and endometrial cancer survivors compared to placebo. The frequency and severity of hot flushes will be recorded on selfreporting patient diaries. Effectiveness of folic acid supplementation on other menopausal symptoms, and quality of life will also be investigated. If folic acid is demonstrated to be effective, it would represent a cheap, safe, well tolerated and easily deliverable alternative to the conventional hormone replacement therapy, particularly in cancer survivors who may be experiencing more intense symptoms and certainly cannot take hormone replacement.

PATHOS

NIHR Porfolio Study ID: 18645

Oropharyngeal cancer caused by Human Papillomavirus (HPV) infection is increasing in incidence in the UK and other developed countries. It affects younger patients and has a better prognosis than most other head and neck cancers.
Patients cured of their disease often have to live for several decades with the side effects of their treatment which can be permanent and have a major impact on quality of life. 

The main objectives of the PATHOS study are:

  • To assess whether swallowing function can be improved following transoral resection of HPV-positive OPSCC, by reducing the intensity of adjuvant treatment protocols. The aim is to personalise treatment, based on disease biology (HPV status and pathology findings), to optimise patient outcomes.
     
  • To demonstrate feasibility of recruitment- if the phase II recruits successfully, PATHOS will continue to a Phase III study aiming to show non-inferiority of survival in the reduced intensity treatment arms.

True NTH UK Post Surgical Follow Up

NIHR Porfolio Study ID: 19493

The True NTH UK Post Surgical Follow up Programme will focus on using patient reported outcome measures (PROMs) to assess the extent and timeline for recovery of urinary and sexual function after radical surgery for prostate cancer. A new instrument will be developed for radical prostatectomy that can be used with men in the UK to monitor their recovery in the first 12 months after surgery. It is envisaged that the PROMs data will be used in clinical practice to monitor progress in outcomes for individual patients. The programme will also allow a comparison of results of surgeons and hospitals against appropriate benchmarks for urinary and sexual outcomes after radical prostatectomy.

ENRICH Ibrutinib for untreated mantle cell lymphoma

NIHR Porfolio Study ID: 19626

Mantle cell lymphoma is a rare but aggressive form of non hodgkins' lymphoma that typically affects older patients.

For younger, fitter patients the most effective treatment is considered to be stem cell transplantation. For older patients, this is not an option and they are generally offered a combination of chemotherapy and rituximab.

The aim of this study is to compare the effect on progression-free survival of treatment with ibrutinib given in combination with rituximab (IR) against treatment with standard chemotherapy given in combination with rituximab.

EASI SWITCH v1.0

NIHR Porfolio Study ID: 20228

Neutropenic sepsis is a potentially life-threatening complication of chemotherapy caused by a condition known as neutropenia, in which the number of white blood cells (called neutrophils) in the blood is low. Neutrophils help the body to fight infection. People receiving chemotherapy for cancer treatment can be at risk of neutropenic sepsis because these treatments can temporarily lower the number of neutrophils in the blood. There is universal agreement that prompt antibiotic treatment is required, but less agreement about how best to manage patients thereafter. This study aims to find out whether changing from intravenous antibiotics (administered into a vein) to oral antibiotics on the first day of treatment is clinically and cost-effective in comparison with longer duration intravenous antibiotics in patients at low risk of complications. 

Who can participate?

Patients undergoing chemotherapy who are admitted to hospital with low risk neutropenic sepsis.

SCOPE 2

NIHR Porfolio Study ID: 20358

SCOPE 2 (Study of Chemoradiotherapy in Oesophageal cancer with PET and dose Escalation) is a Cancer Research UK funded trial recruiting patients across the UK with oesophageal cancer. 

This trial aims to answer two important questions:

1) Does increasing the dose of radiotherapy improve patient outcomes? Research has shown that increasing the dose of radiotherapy improves outcomes in patients with lung and head and neck cancers. This study aims to see whether this is also the case for patients with oesophageal cancer.

2) Additionally, we also want to find out whether patients may benefit from receiving a different type of chemotherapy if they do not show an early response to standard chemotherapy drugs.

MDSBio

NIHR Porfolio Study ID: 2507

Molecular and functional characterisation of bone marrow function in normal subjects, myelodysplastic syndromes (MDS), acute myeloid leukaemia (AML) and secondary disorders of haematopoiesis.

PARTNER

NIHR Porfolio Study ID: 30433

This is a clinical trial for patients diagnosed with early stage breast cancer i.e. that has not spread to other organs such as the lungs, liver or bones, who have been advised to receive chemotherapy before surgery (neoadjuvant) chemotherapy. The trial investigates the safety and effectiveness of olaparib, a drug which targets part of the pathway that repairs damaged DNA, in addition to platinum-based neoadjuvant chemotherapy. 

The trial is open to patients who have breast cancer caused by an inherited mutation (change from the normal DNA sequence) in the BRCA 1 or BRCA 2 genes. In addition, it is open to patients who do not have hormone-responsive (oestrogen) breast cancer that also does not over-express a protein called HER2.

Prepare-ABC

NIHR Porfolio Study ID: 30965

This trial is designed to look at whether an exercise intervention would be beneficial to patients pre and post hospital discharge when undergoing curative colorectal surgery. The trial is multi-centre, single blind (assessors only), 3-arm, randomised, controlled, recruiting colorectal cancer patients at point of diagnosis, within colorectal units in UK hospitals. 

This trial will compare standard care alone versus standard care plus supervised hospital based exercise and standard care plus supported home based exercise, undertaken 4 weeks pre-surgery and resuming 6 weeks post-surgery.

HORIZONS: Understanding the impact of cancer diagnosis and treatment 

NIHR Porfolio Study ID: 31610

HORIZONS is a cohort study to explore recovery of health and well-being in adults diagnosed with cancer. Experiences and outcomes of cancer treatment and care are changing. A growing number of people are experiencing cancer not as a life-limiting disease, but as a life-changing and long-term condition. There is a growing imperative to understand the changing landscape of cancer and its consequences: as we do so, we will be better able to inform the design and delivery of cost effective interventions that make possible supported self-management, as well as service organization and delivery.

The key research questions are: 

  • What impact does cancer and its treatment have on the lives of people diagnosed with cancer in the short, medium and long term? 
  • What are the health outcomes, experiences and self-management activities over the life-course across different cancer types and who and what influence these?

STATEC

NIHR Porfolio Study ID: 31860

The primary aim of this trial is to determine whether lymphadenectomy, used to restrict adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a non-inferior survival as compared to adjuvant therapy given to all women with high risk apparent stage 1 endometrial cancer.

Patients with histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer can participate. 

Myeloma XII (ACCoRd trial) Version 1.0

NIHR Porfolio Study ID: 32907

This phase III trial aims to determine and compare:

  1. The depth of response between standard melphalan conditioning and augmented (adding ixazomib) melphalan conditioning at second ASCT.
     
  2. The impact of adding consolidation and maintenance treatment versus no further treatment, on progression free survival.

MUK nine a: screening study

NIHR Porfolio Study ID: 33204

An observational and screening study to identify high risk myeloma patients suitable for novel treatment approaches and determine treatment outcomes for non-high risk myeloma patients. The aim of this phase II study is to assess whether future trials in this setting are feasible, and to determine risk status for participants with myeloma, in order to recruit high risk participants into MUK nine B. 

Participants who are found to be high risk and who are eligible will be provided with information on MUK nine B. Participants who are found not to be high risk will be treated according to NICE standard treatment (which may include other clinical trials).

National cohort study of late effects of Hodgkin lymphoma treatment

NIHR Porfolio Study ID: 33808

This study proposes to investigate a range of clinically significant co-morbidities which develop in female Hodgkin Lymphoma survivors treated in childhood and young adulthood.
 
This study will collect and analyse treatment and co-morbidity information on women treated for Hodgkin Lymphoma across England and Wales at ages ≤35 years during 1956-2010. We will expand an existing national cohort study of 5,000 women treated for Hodgkin Lymphoma, the largest of its kind in the world, which has undertaken research to inform the risks of developing breast cancer after Hodgkin Lymphoma treatments.

ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL)

NIHR Porfolio Study ID: 34646

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.

While PARP inhibitors have demonstrated consistent robust clinical activity in patients with relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and safety of PARPi versus standard of care chemotherapy have been limited. 

The primary purpose of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in their tumor.

DANTE (Duration of Anti-PD1 therapy for melanoma)

NIHR Porfolio Study ID: 35180

This trial aims to determine whether anti-PD1 monotherapy to treat advanced melanoma can be stopped after 1 year, rather than the current standard practice (i.e. continuing to treat until disease progression/unacceptable toxicity, or for at least 2 years), and achieve and maintain as good an outcome (in terms of the cancer coming back). 

The hypothesis is that continuing treatment beyond 1 year is unnecessary, as there is no biological evidence that justifies continuous therapy; many responses occur in the first year and can continue even after treatment is stopped. Also, continuing treatment exposes patients to an increased risk of developing immune-related toxicities and is a considerable burden to patients and the National Health Service.

The EASEMENT Study

NIHR Porfolio Study ID: 36843

Observational study to evaluate the burden of injected and oral treatment formulations in the treatment of multiple myeloma patients.

Ovarian Microenvironment (OM)

NIHR Porfolio Study ID: 36879

The study is a prospective single-site, lab-based investigation which will use ovarian samples, samples from metastatic lesions, ascitic fluid and blood samples from patients undergoing gynaecological investigation or surgery.

Show RESPECT v1.0

NIHR Porfolio Study ID: 38631

The Show RESPECT study is trying to find practical ways to share the results of clinical trials with the people taking part in it. It is doing this by testing several different approaches within a large ovarian cancer trial (the ICON8 trial). 

Each site that is taking part in ICON8 in the UK will be allocated at random to share the results of the study in one or more of the following ways:

  • a link to a basic webpage that contains a simple summary of the results. 
  • a link to an ‘enhanced’ webpage that contains a simple summary of the results, links to further information, a short video of a doctor explaining the results, and a ‘frequently asked questions’ section that answers questions people send in.
  • a simple printed summary of the results.
  • inviting people taking part in the trial to join an email list, where a summary of results and updates will be sent out.

UK Genetic Prostate Cancer Study (UKGPCS)

NIHR Porfolio Study ID: 869

The UKGPCS was set up to find genetic alterations which occur in patients who have prostate cancer.

A man's risk of developing prostate cancer increases if he has a first-degree relative (father or brother) who was diagnosed with prostate cancer at a young age. This study is looking for men who are affected at a young age or who have a family history of prostate cancer, since it is more probable that these prostate cancers are due to an inherited genetic cause rather than an environmental cause.

Men who come to the hospital to be treated for prostate cancer will be asked if they would like to take part in the study so that to explore if we find genetic alterations in older men, and those who do not have a family history of prostate cancer.

ICON8 and ICON8B - ICON8 Trial Programme

NIHR Porfolio Study ID: 9812

ICON8: An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer.

ICON8B: A phase III randomised trial investigating the combination of dose-fractionated chemotherapy & bevacizumab compared to either strategy alone for the first line treatment of women with newly diagnosed high risk stage III-IV epithelial ovarian, fallopian tube or primary peritoneal cancer.

 

Cardiovascular

Current recruiting studies:

Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

NIHR Porfiolio Study ID: 14922

This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

The British Heart Foundation SENIOR-RITA Trial

NIHR Porfiolio Study ID: 31707

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time to cardiovascular death or non-fatal MI within one year from randomization.

 

Dementias and Neurodegenerative Diseases

Current recruiting studies:

Nigrosomal Iron Imaging in Parkinson’s Disease (N3iPD)

NIHR Porfiolio Study ID:32859

Parkinson’s is a progressive condition gradually destroying specific nerve cells in the brain which leads to impaired movement control and to other dysfunctions. Detecting Parkinson’s can be very difficult especially in the early stages. If in doubt, treating doctors can ask for a so called “DaTSCAN™” to help them establish the diagnosis. However, this test is not widely available, very expensive and involves injection of a radioactive substance. A promising alternative Magnetic Resonance Imaging (MRI) test has been developede that can detect established Parkinson’s based on increased iron content in the ‘nigrosomes’ which are tiny brain regions, most affected by the condition. 

This study will test whether our nigrosome MRI test is as useful as DatSCAN to establish the correct diagnosis in people with minor or unclear symptoms suspicious for Parkinson’s. 

 

Diabetes

Current recruiting studies:

StartRight Study

NIHR Porfiolio Study ID:31209

This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1000 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. The investigators will recruit an additional cohort of 800 participants diagnosed after age 50. The investigators will record clinical features and biomarkers that may help us to determine diabetes type at diagnosis and follow participants for 3 years to assess the development of severe insulin deficiency (measured using C-peptide) and insulin requirement. The investigators will assess utility of clinical features and additional biomarkers in identifying patients with rapid progression to insulin requirement. Findings will be integrated into a freely available clinical prediction models to assist classification of diabetes at diagnosis.

Chronotype of Patients with Type 2 Diabetes and Effect on Glycaemic Control: The CODEC Study

NIHR Porfiolio Study ID: 32591

In this cross-sectional observational study, the investigators propose to extensively chronotype a sample of patients with Type 2 Diabetes, and to determine the impact of chronotype on glycaemic control, insulin resistance, biochemical profile, and inflammatory, adipocytokine and genetic markers using a validated questionnaire and blood tests.

In an optional sub-study they will explore the association between chronotype and objectively measured physical activity, energy intake and clock genes.

DISCOVERY - Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers

NIHR Porfiolio Study ID: 33329

A European prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of diabetic foot ulcers (DFUs).

ADDRESS C-Peptide

NIHR Porfiolio Study ID: 34038

At diagnosis of type 1 diabetes (T1D), many people still make some insulin in their own bodies and this declines over time. In this sub-study of the ADDRESS-2 study we want to investigate how the ability to make insulin changes during the first year after diagnosis in children and adults. We want to find out how it varies with other characteristics of T1D. Understanding this better might help to identify people in the future who are best-suited to new treatments for T1D.

We want to investigate whether C-peptide measured in a urine sample collected at home after an evening meal is a valid and practical method for people recently diagnosed with T1D.

CADOM

NIHR Porfiolio Study ID: 35344

The aim of the study is to assess the feasibility of using serial MRI to reduce treatment times in Charcot in people with diabetes. This study will be a feasibility study and patients will be recruited from hospital run Diabetic Foot Clinics.

 

Sleep T2D Trial - The impact of sleep disorders in patients with type 2 diabetes

NIHR Porfiolio Study ID: 37844

Type 2 diabetes (T2D) is very common and has a huge burden on patients, carers, and the NHS. Much of the burden of T2D is due to blockages in the small blood vessels, leading to eye, kidney, nerve and foot problems. Around two thirds of patients with T2D also have obstructive sleep apnoea (OSA). OSA is a condition where there are episodes of complete or partial blockage to the windpipe during sleep. This causes a short reduction in breathing. OSA might contribute to small blood vessels disease in T2D, so it is important to examine the impact of OSA treatment on diabetes-related blood vessels disease. 

The aim of this study is to assess the feasibility of conducting a larger study of the impact of OSA treatment on diabetes-related blood vessels disease. The results could help identify new treatment targets that will reduce the burden of T2D.

ADDRESS-2: Incident and high risk type 1 diabetes cohort

NIHR Porfiolio Study ID: 9689

Project website: www.address2.org

This research project is learning about the characteristics of people newly diagnosed with type 1 with diabetes in the UK, and at the same time supporting other research into type 1 diabetes. Children and adults aged 5 or older and newly diagnosed with type 1 diabetes, who are willing to let us collect information about their diabetes, and who also agree to be contacted about other opportunities to take part in type 1 diabetes research are eligible to take part. We are looking for siblings to help too.

Ear

Current recruiting studies:

Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP)

NIHR Porfiolio Study ID: 38013

This study aims to identify which Recurrent Respiratory Papillomatosis (RRP) treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment. 

This observational study does not require patients to undergo any additional intervention as part of the research.

 

Eye

Current recruiting studies:

EuPatch (European Paediatric Amblyopia Treatment Study for Children): the role of glasses wearing in amblyopia treatment

NIHR Porfiolio Study ID: 15004

Amblyopia (also called lazy eye) is the most common disease affecting vision in childhood. Currently 30% of children treated for amblyopia do not reach normal vision after a year or more of treatment. Amblyopia is usually treated with glasses wearing and by patching the better eye (wearing an eye patch). There is controversy whether a long period of glasses wearing before patching, called refractive adaptation, helps in treating children with amblyopia. The aim of this study is to perform a trial to test whether refractive adaptation before patching improves the number of successfully treated children with amblyopia. 

Adjunctive Steroid Combination in Ocular Trauma (ASCOT) Study

NIHR Porfiolio Study ID: 17226

Eye trauma is a leading cause of blindness and visual impairment. Penetrating injuries of the eye are more likely to result in poor vision and the main cause of this is a scarring response on the retina (proliferative vitreoretinopathy, PVR) The purpose of this study is to investigate the potential of an anti-inflammatory treatment (triamcinolone acetonide) to improve the outcome of surgery in eyes that have suffered severe trauma.

Stereotactic radiotherapy for wet age-related macular degeneration (AMD): (STAR)

NIHR Porfiolio Study ID: 18040

This study investigates the use of radiation to treat wet age-related macular degeneration (AMD). The radiation is delivered using a robotically controlled device that projects overlapping beams of radiation onto the macula, the part of the eye that is affected by wet AMD. The study aims to determine if stereotactic radiotherapy can maintain vision and reduce the need for such regular anti-VEGF injections.

 

Generic Relevance & Cross Cutting Themes

Current recruiting studies:

NephroS: The National Study of Nephrotic Syndrome (NURTuRE)

NIHR Porfiolio Study ID:7945

A study to correlate the epidemiological and clinical features of Steroid Resistance Nephrotic Syndrome including Focal Segmental GlomeruloSclerosis (FSGS) in childhood and Adulthood, in the UK, with genotype and to develop biomarkers of disease activity post transplant.

 

Genetics and Congenital Disorders

Current recruiting studies

100,000 Genomes Project Bioresource (Main phase)

NIHR Porfolio Study ID: 37319

Project website: www.genomicsengland.co.uk

In December 2012, the Prime Minister announced a programme of whole genome sequencing (WGS) as part of the UK Government’s Life Sciences Strategy. The principal objective of the 100,000 Genomes Project is to sequence 100,000 genomes from patients with cancer, rare disorders, and infectious disease, and to link the sequence data to a standardised, extensible account of diagnosis, treatment, and outcomes.

The Project is designed to produce new capability and capacity for genomic medicine that will transform the NHS. It will also produce new capability for clinical genomics research. As part of the proposal a secure infrastructure will be established for the protection and analysis of clinical and genomic data. This will be made available for approved academic and industrial research purposes, including those of the contributing clinical organisations from the NHS.

Molecular Genetics of Adverse Drug Reactions (MOLGEN)

NIHR Porfolio Study ID: 8630

Adverse drug reactions (ADR's) are a common cause of drug-related morbidity and may account for about 6.5% of all hospital admissions. The purpose of this research is to (a) identify patients with different types of adverse drug reactions; (b) using DNA obtained from blood or Saliva samples from these patients, identify genetic factors which predispose to adverse reactions. 

We aim to recruit 250 cases for each reaction for a period of eight years throughout multiple sites in the UK. 

Sequencing Based Analysis of SLE

NIHR Porfolio Study ID: 13262

The aim of this research is to discover the genetic factors that increase the risk of developing Systemic Lupus Erythematosus (SLE) using high-throughput genome sequencing technologies. This type of sequencing allows more variants to be sequenced with greater accuracy.

We will collect blood from patients with SLE, who satisfy the specific criteria for disease classification, as well as healthy controls.

 

Hepatology

Current recruiting studies:

The UK-PBC Nested Cohort Study (version 1)

NIHR Porfiolio Study ID: 17542

The pharmaceutical industry has a major interest in finding novel medications for ursodeoxycholic acid (UDCA) non-responders.However, the biological mechanisms of UDCA responsiveness are unknown, which impedes drug discovery and precludes an informed decision about which medications should be prioritised for clinical trials. 

In the UKPBC Nested Cohort Study, we aim to elucidate the biological mechanisms of UDCA responsiveness. To do this, we will recruit known UDCA non-responders and matched UDCA responders from the UKPBC Research Cohort, a cohort of approximately 4500 PBC patients that has been established for population-level studies of PBC. We will also recruit treatment-naive PBC patients who presented before the age of 50.

Albumin To prevenT Infection in chronic liveR failurE (ATTIRE)

NIHR Porfiolio Study ID: 18450

Currently infection in liver patients is treated with antibiotics, however the rates of death in these patients have shown little improvement over 20 years. Antibiotics may also cause harmful side-effects (e.g. diarrhoea) and overuse has led to antibiotic resistant bacteria which makes these drugs useless and will be one of medicines’ greatest challenges over the next decade.

This study aims to see if giving liver patients Human Albumin Solution restores their immune response and helps both prevent and improve treatment of infections.

B-SMaRT study

NIHR Porfiolio Study ID: 32534

This study aims to investigate whether MRI can accurately detect changes in portal pressure after treatment with beta-blockers in order to identify which patients are responding to treatment. 

Cirrhosis patients on the beta-blocker Carvedilol will be invited to take part in this study and as a result of this will have their portal pressures measured by both  hepatic venous pressure gradient (HVPG) and MRI. We hope this study will tell us whether MRI can be used instead HVGP in the future and prevent the need for more invasive tests.

The REVERSE study

NIHR Porfiolio Study ID: 37682

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH). The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

CALIBRE Study

NIHR Porfiolio Study ID: 39255

People with long standing liver disease called cirrhosis (scarring of the liver) can develop enlargement of veins in the gullet (food pipe) known as ‘oesophageal varices’. Patients with medium to large oesophageal varices have a 1 in 3 chance of these veins bleeding. In very severe cases, this could result in death. It is therefore important to lower the risk of this bleeding. At present, all people with medium to large oesophageal varices are offered one of two treatments to lower the risk of bleeding either beta blockers or variceal band ligation. 

CALIBRE aims to compare carvedilol with banding in people with cirrhosis who have medium to large varices that have never bled. This will be done by observing which treatment is effective in stopping bleeding of varices in the first 12 months after randomisation.

PBC Genetics Study

NIHR Porfiolio Study ID: 5630

The PBC Genetics Study is a national effort to establish a PBC DNA collection consisting of DNA samples from approximately 5000 patients with PBC. The DNA collection has already been used for a genome-wide association study (GWAS) of PBC.  The next major analysis will be a genome wide association study of response to Ursodeoxycholic acid (UDCA).

UK-PSC

NIHR Porfiolio Study ID: 6388

The aim of this study is to investigate whether patients with primary sclerosing cholangitis (PSC) or autoimmune hepatitis (AIH) can be safely and effectively treated with a therapy called mesenchymal stromal cells (MSC). 

 

Infection

Current recruiting studies:

Clinical Characterisation Protocol for Severe Emerging Infection

NIHR Porfiolio Study ID: 14152

This study is designed for the rapid, coordinated clinical investigation of patients with confirmed novel coronavirus infection. The study has been designed to maximize the likelihood that as much data as possible is collected and shared rapidly in a format that can be easily aggregated, tabulated and analysed across many different settings globally. The study is designed to have some level of flexibility in order to ensure the broadest acceptance.

ASPIRE-SSI

NIHR Porfiolio Study ID: 35661

Project website: https://www.combacte.com/

Surgical site infections (SSIs) cause considerable morbidity, mortality and costs. Staphylococcus aureus is a bacterium (a bug) which commonly causes SSI. The patterns, causes and effects of S. aureus SSI have not been fully described, but this kind of information is urgently needed for the development of preventive interventions against S. aureus SSIs.

This study aims to assess the incidence of SSI caused by S. aureus up to 90 days following surgery and determine any risk factors. Adult patients (18 years of age or older) undergoing 1 or more of the protocol-listed surgical procedures are eligible but enrolment in the study cohort population will be based on preoperative S. aureus colonisation.

The A-Stop Study: Antifungal stewardship opportunities with rapid tests for fungal infection in critically ill patients.

NIHR Porfiolio Study ID: 38139

Treatment with ‘antifungal’ drugs is started when patients are thought to be at risk of fungal infection, even though the large majority turn out not to have this infection. This leads to the clinical problem that is over-prescription of drugs used to treat Candida fungal infection in adults and children in intensive care units (ICU). 

 This study evaluates how accurately three different rapid tests can diagnose fungal infection in adults and children, started presumptively on antifungal treatment. The clinical and economic impact of implementing these rapid tests, based on how accurately they diagnose fungal infection will be determined. The study results will be used to develop a guideline that could be used by ICU staff to reduce unnecessary antifungal drug use.

 

Meds for Children

Current recruiting studies:

Genetic Determinants of Kawasaki Disease

NIHR Porfiolio Study ID: 14822

The aim of the study is to identify the genes underlying susceptibility to Kawasaki Disease, and also underlying differing sequelae of the disease such as coronary artery aneurysms. Identification of the genes involved will help to improve understanding of the disease, and the development of better treatments, and identification of those most at risk of developing coronary artery aneurysms.

Baby-OSCAR Trial

NIHR Porfiolio Study ID: 18528

Babies born prematurely commonly have a condition referred to as Patent Ductus Arteriosus (PDA). This is when the blood vessel (Ductus Arteriosus) that allows blood to bypass the baby's developing lungs to the mother's placenta during pregnancy remains open after birth.

The aim of this study is to find out whether identifying and treating these babies improves both their short and long term health.

CAP-IT

NIHR Porfiolio Study ID: 31305

Amoxicillin is the antibiotic most commonly used for pneumonia in children. The CAP-IT trial will look at whether lower doses and shorter duration of amoxicillin are as good at treating pneumonia as higher doses and longer duration of treatment.

Parents or carers of children will be asked to join the study if the child has pneumonia and will be treated with amoxicillin.

RAACENO

NIHR Porfiolio Study ID: 34390

Using Fractional exhaled Nitric Oxide (FeNO) measurements in breathed out air may improve asthma control.  This study will investigate this in children with asthma.  Children aged 6-16 years with a diagnosis of asthma, who currently use inhaled corticosteroids and who have had an asthma exacerbation in the previous 12 months are eligible.

CHIPS+

NIHR Porfiolio Study ID: 35407

For young people who acquired HIV perinatally or in early life (hereafter referred to as PHIV), the process of transition from paediatric to adult care is key to shaping ongoing and future HIV care engagement as well as short to medium-term health outcomes. 

This observational cohort study will address the following  research questions:

  1. What are the health outcomes of PHIV after transition to adult care in the UK/Ireland? Do these outcomes differ by the type of adult clinic: (i) standard adult HIV clinics, mostly based in Genitourinary Medicine (GUM) /sexual health clinics, versus (ii) specialised young persons’ clinics?
  2. What factors shape PHIV care engagement after transition?

Parental mindfulness and wellbeing in childhood psoriasis

NIHR Porfiolio Study ID: 37915

Psoriasis is a chronic inflammatory skin disorder that affects around 2% of children. Childhood psoriasis is associated with poorer mental health and quality of life in both children and their parents. Parental stress, in particular, appears to be an important contributing factor to poorer mental health and poorer skin condition in children. Little research has investigated factors which may reduce parental stress.

The main aim of the current study is to investigate the relationship between mindful parenting, and parental and child quality of life. In part one, parents and children will be asked to complete self-report questionnaires assessing: mindful parenting, parental stress, quality of life, mental health, and psoriasis and itch severity. Part two of the study adopts a qualitative research design and involves face-to-face interviews with 12 children and their parents about their experiences of living with psoriasis.

iGBS feasibility study

NIHR Porfiolio Study ID: 38500

Group B Streptococcus (GBS) is a bacterium (germ) that can cause serious infections such as meningitis, blood poisoning and pneumonia in newborns. Infection during the first 6 days of life may be prevented by antibiotics given to the mother during labour, but will offer no protection for infections occurring later.

The aim of this smaller (feasibility) study is to assess the recruitment and test the methods. If this feasibility study works well this will lead to a larger study to address the question of how much antibody is needed to protect against invasive infant GBS disease. Participants will be pregnant women of at least 18 years of age.

Clinical Study of the Solo Advance Tympanostomy Tube Device

NIHR Porfiolio Study ID: 39369

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD).

TrialNet: Pathway to Prevention Study

NIHR Porfiolio Study ID: 4016

The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. 

The TrialNet Natural History Study of the Development of T1DM has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM.

 

Metabolic and Endocrine

Current recruiting studies

The Utility of Routine Pathology Results for Identifying Rare Diseases

NIHR Porfolio Study ID: 17588

There are a very large number of such rare diseases that doctors do not think about because they are very rare and therefore very unlikely. As a result, patients with these diseases are often diagnosed very late so potentially beneficial treatments may not be given when they could best assist the patient.

Every day thousands of pathology tests are carried out in laboratories across the country. If that data could be linked to identify features that may be suggestive of a rare disease, it may be possible to carry out screening programs to find people who could benefit from early treatment.

The preliminary 'CESD' project has demonstrated that patients are very happy to have their results examined in this way and are keen to be tested. This project expands on the previous single disease project.

 

Musculoskeletal

Current recruiting studies:

Fatigue Fingerprints

NIHR Porfiolio Study ID: 12530

Chronic fatigue is an important health problem and is associated with huge economic cost. However, little is known about the underlying biological mechanisms of chronic fatigue, and at present there is no effective treatment for chronic fatigue.

In this study, we will:

  1.  Measure the levels of gene expression of the entire genome and the levels of proteins or other small molecules in the blood of patients with primary Sjogren's syndrome (PSS) and those with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) (chronic disabling fatigue is a common complaint of patients suffering from both conditions), in order to identify a biological "signature" that discriminates levels of fatigue.
  2. Determine whether such biological signature of fatigue may be useful for monitor treatment of fatigue as well as the diagnosis of CFS/ME.

UKIVAS

NIHR Porfiolio Study ID: 12689

Primary systemic vasculitidies (PSV), encompassing Anti-Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis and medium vessel vasculitis, are relatively uncommon diseases, but have a propensity for renal involvement and account for a significant number of patients with both acute and chronic kidney disease. 

We propose to establish the first pan-UK PSV dataset, which will collect regular returns regarding patient recruitment and outcome from all participating centres. This will facilitate investigation of disease associations, outcomes and demographic trends for the UK PSV population. We will test the hypothesis that disease incidence is increasing in Indo-Asians and why the outcome may be different among different ethnic groups, as well as investigating contemporary outcomes with modern immunosuppressive protocols.

Genetics - Identification of disease susceptibility genes and autoantibodies associated with the development and clinical characteristics of interstitial lung disease (ILD) in patients with and without proven connective tissue diseases (CTDs).

NIHR Porfiolio Study ID: 15775

Identification of disease susceptibility genes and autoantibodies associated with the development and clinical characteristics of interstitial lung disease (ILD) in patients with and without proven connective tissue diseases (CTDs).

MYOPROSP

NIHR Porfiolio Study ID: 20606

Idiopathic Inflammatory Myopathies (IIM), also know as myositis, is a rare condition that causes inflammation of the muscles and can result in weakness, fatigue and disability. It can also affect other parts of the body including the skin, joints, heart, lungs and digestive tract. Treatment involves the suppression of inflammation using anti inflammatory medication before permanent damage results. However, the outcome for patients with myositis is not as good as it could be and needs to be improved. This research study aims to find better ways to diagnose, treat and improve the care of patients with myositis. 

GCA Consortium: Clinical and immunogenetic characterization of Giant Cell Arteritis (GCA) and polymyalgia rheumatica (PMR)

NIHR Porfiolio Study ID: 2879

This is designed as an immunogenetic study of giant cell arteritis and polymyalgia rheumatica. The UK GCA Consortium aims to identify genetic determinants of Giant Cell Arteritis (GCA) and polymyalgia rheumatica (PMR) susceptibility in order to yield novel insights into disease pathogenesis. The ultimate aim is to conduct a genome-wide association study of these diseases.

The GRASP Trial

NIHR Porfiolio Study ID: 31551

Currently we don’t know what is the best type and amount of physiotherapy for rotator cuff (RC) problems, even though it is often used. We also don't know whether patients do better if they get an injection called a steroid before starting any physiotherapy. 

This trial will test whether people with a RC problem do better after up to 6 physiotherapy sessions or after one best-practice advice session with a physiotherapist. The trial will also test whether getting an injection in the shoulder joint before starting either regime helps. All of the treatments included are already commonly used in the NHS to treat RC pain. This trial is recruiting individuals with a new episode of shoulder pain due to a RC problem and who have not received any physiotherapy.

 

DRAFFT 2 - Distal Radius Acute Fracture Fixation Trial 2

NIHR Porfiolio Study ID: 31693

A Randomised Controlled Trial of Manipulation and surgical fixation with K-wires versus Manipulation and Casting in the Treatment of Adult Patients with a Dorsally Displaced Fracture of the Distal Radius.

DISC - Dupuytren's Interventions Surgery vs Collagenase

NIHR Porfiolio Study ID: 33417

A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren’s contracture in adult patients.

COMPACT, version 1.0

NIHR Porfiolio Study ID: 35714

Complex Regional Pain Syndrome (CRPS)is a persistent pain condition that remains incompletely understood and challenging to treat. Currently, it is difficult to bring research findings from many different studies together because researchers may not always use the same questionnaires. There is therefore limited evidence on the causes, course and best management of CRPS. An international group of patients, clinicians, researchers and industry representatives has agreed a minimum set of questionnaires (COMPACT©) for use in future CRPS clinical studies in adults. 

The aim of this study is to test how practical it is to collect research data from patients with CRPS using a core set of questionnaires (COMPACT©).

Work outcome measures in arthritis and musculoskeletal conditions

NIHR Porfiolio Study ID: 35783

Many people with arthritis struggle at work. Therapists and researchers need good quality assessments to find out: the work problems of working people with arthritis; what services can help them; if work rehabilitation helps; and how arthritis affects working lives. To do this, assessments must ask about what people with arthritis  think is important.

We will adapt and test seven self-report assessments, developed in Canada, for the UK. Working people with arthritis, identified from out-patient occupational therapy, physiotherapy or rheumatology  departments, patient organisations or research volunteers are eligible to take part.

The RaCeR study: Rehabilitation following Rotator Cuff Repair

NIHR Porfiolio Study ID: 38705

Disorders of the muscles and tendons of the shoulder, the rotator cuff (RC), are the most common cause of shoulder pain. The number of operations to repair the torn RC has increased significantly over recent years. We do not know when rehabilitation after surgery should begin. Currently most patients are advised to rest their arm in a sling for four to six weeks after the operation. But, evidence suggests that starting rehabilitation early (as soon as possible after surgery) might help people return to their usual activities more quickly, which is important to patients.

RaCeR is a pilot and feasibility randomised controlled trial aiming to assess the feasibility of conducting a larger, main trial. Patients will receive one of two rehabilitation programmes; early patient-directed mobilisation (movement), using pain as a guide, or immobilisation of the arm in a sling for four weeks. 

BRAGGSS Study

NIHR Porfiolio Study ID: 5114

Project website: http://www.braggss.co.uk/

The BRAGGSS Study collects data from patients receiving biologic therapy to evaluate the role of genetic variation, psychological status, clinical variables, serological measures and environmental factors in determining response to treatment.

There are two parts to the study: 

  1. The Cross Sectional Arm - for patients on an anti TNF drug and registered on the BSRBR. One single blood sample required for DNA testing.
  2. The Prospective Arm - for new patients about to start an anti TNF drug. We will be collecting the clinical, serological, psychological and genetic data in place of the BSRBR.

Molecular basis of chronic inflammatory and degenerative diseases

NIHR Porfiolio Study ID: 6207

This study aims to perform basic research into the causes of arthritis and other inflammatory diseases, and help to develop preventative and therapeutic interventions.

Patient blood and waste tissue from surgical interventions will be used to set up explant cultures to characterise the cells involved in the disease process, identify novel gene signatures and to test new therapies.

Toxicity from biologic therapy (BSRBR)

NIHR Porfiolio Study ID: 7302

The BSRBR-RA study tracks the progress of people with rheumatoid arthritis (RA) who have been prescribed biologic (including biosimilar) and other targeted therapies in the UK, to monitor the long-term safety of these drugs.

Investigating genes in patients with polymyositis and dermatomyositis

NIHR Porfiolio Study ID: 7996

Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM) belong to a group of inflammatory muscledisorders, of unknown cause, that are characterised by skeletal muscle nflammation and progressive muscularweakness, which can be debilitating and chronic in nature (occasionally fatal). The current treatment options for these conditions are steroids and various other immunosuppressive drugs. However, these are usually only partially effective at reducing symptoms, and their toxic side effects also limit their usefulness.

In order to understand the genetic aspects / causes of myositis, and ultimately develop more effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to give 20 mls of blood. These blood samples, along with the patient’s clinical details, will then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University of Manchester, where all of the genetic analyses will take place.

BILAG Biologics Prospective Cohort

NIHR Porfiolio Study ID: 8251

Project website: http://www.bilagbr.org/index.asp 

The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, non-biologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort.

United Kingdom Primary Sjogren's Syndrome Cohort

NIHR Porfiolio Study ID: 8594

The aim of this project is to create a cohort of well-characterised Primary Sjogren's Syndrome (PSS) patients in order to facilitate such proof-of-concept clinical trials, observational and longitudinal studies in PSS. PSS patients will be identified from existing databases of the collaborating hospitals.

 

Neurological

Current recruiting studies:

MND Register for England, Wales and Northern Ireland

NIHR Porfiolio Study ID: 20690

The motor neuron disease (MND) Register is the first comprehensive source of information about MND in England, Wales and Northern Ireland. Patients are eligible if they have been diagnosed with MND by a consultant neurologist and live in England, Wales or Northern Ireland.

Biology of Juvenile Myoclonic Epilepsy

NIHR Porfiolio Study ID: 34096

Epilepsy is a common neurological disorder affecting 1% of the population. There are over 30 types of epilepsy, some common, some rare. Most epilepsies arise in childhood and have a genetic cause. Approximately 40% of patients have the common forms of Genetic Generalised Epilepsy (GGE), and the commonest GGE is “Juvenile Myoclonic Epilepsy” or JME. 

The goal of this study is to find the genetic cause for JME. We will do this by comparing the genetic code in JME patients with that in people who do not have epilepsy. We will use clues from their electroencephalograph or brainwave test that is used to help diagnose epilepsy.

 

Obstetrics & Gynaecology

Current recruiting studies:

Pipelle for Pregnancy (PIP) studies

NIHR Porfiolio Study ID: 30926

Studies that have investigated the application of local endometrial biopsy (LEB) prior to IVF/ICSI have focussed on participants with recurrent implantation failure undergoing fresh embryo transfers. The procedure appears to be beneficial however the available evidence is associated with a high risk of bias and so the real benefit remains controversy. Further, its effectiveness in women undergoing frozen-thaw transfer or first time IVF has not been addressed.

The PIP studies will address these gaps by conducting three separate trials in women undergoing IVF/ICSI and attempted natural conception.

 

Oral and gastrointestinal

Current recruiting studies:

PRED 4 - Predicting Serious Drug Side Effects in Gastroenterology

NIHR Porfiolio Study ID: 11988

Project website: https://www.ibdresearch.co.uk/pred4/

This is a group of studies looking at serious drug side effects in gastroenterology (IBD).

Entyvio (vedolizumab) long-term safety study

NIHR Porfiolio Study ID: 18099

An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn's Disease.

IBD Bioresource

NIHR Porfiolio Study ID: 20664

Working with the NIHR Bioresource, we are proposing to develop a centralised national recallable bioresource of 25,000 patients with Crohn's disease or ulcerative colitis (collectively inflammatory bowel disease / IBD) to support scientific and clinical IBD research. 

The IBD Bioresource will be part of the NIHR Bioresource, and will extend recallable functionality to IBD allowing translation of recent genetic advances.

Long Term Safety of Filgotinib in Active Ulcerative Colitis

NIHR Porfiolio Study ID: 32734

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis.

Efficacy and Safety of Fligotinib in Active Crohn’s Disease

NIHR Porfiolio Study ID: 32741

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active Crohn’s Disease in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study, "Long Term Safety of Filgotinib in Active Crohn’s Disease".

Long Term Safety of Filgotinib in Active Crohn’s Disease

NIHR Porfiolio Study ID: 32785

A long-term extension study to evaluate the safety of Filgotinib in subjects with Crohn’s Disease.

Reclassifying constipation using MRI and high resolution manometry 

NIHR Porfiolio Study ID: 33449

Constipation is a common condition in which an individual suffers with hard stools which are infrequent and difficult to pass. At present we cannot identify what type of abnormality of colonic contractions each individual patient suffers from and so are unable to give them the best treatment. This study will take advantage of two new techniques which have been recently developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of the colon in response to a dose of the laxative Moviprep which increases the flow of fluid into the proximal part of the colon and High Resolution Manometry (HRM) which measures the power and direction of the contraction in much more detail than ever before using a pressure sensing catheter placed into the bowel.

OCTAVO: The impact of vedolizumab on prescribing and quality of life 

NIHR Porfiolio Study ID: 37863

A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland.

 

Paediatrics

Current recruiting studies:

ASPIC - Acute Severe Poisonings in Children

NIHR Porfiolio Study ID: 36861

A secondary care surveillance cohort study, in collaboration with the British Paediatric Surveillance Unit. Paediatricians within UK and Republic of Ireland will report cases through the BPSU ‘orange card’ system as part of this study. These are sent out to all consultant RCPCH members on a monthly basis via email or post. This card includes a list of disorders or conditions currently being studied and the clinicians tick if they have seen a case or tick ‘nothing to report’. This process is defined as ‘active surveillance’ as the card is sent out on a monthly basis and a response is expected.

Petechiae In Children (PIC) Study

NIHR Porfiolio Study ID: 39349

A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children.

In particular the investigators are interested in researching how quick bedside tests can be used to do this.

 

Renal and Urogenital

Current recruiting studies

The UK Calciphylaxis Study

NIHR Porfolio Study ID: 11704

Calciphylaxis is a rare condition which results in small arteries becoming calcified. This results in painful ulceration of the skin which in turn can result in infection and further damage to tissue. It is associated with a high mortality rate (60–80%).

Consequently research into this area is important. The aims of this study are to determine the following:

  1. What is the natural history of the disease?
  2. What risk factors are associated with development and progression of calciphylaxis?
  3. Which treatments currently in clinical practice confer a favourable outcome?
  4.  What are the underlying disease processes?

Renal MRI Feasibility Study in Patients with CKD and AKI

NIHR Porfolio Study ID: 20203

Multi centre observational pilot study using novel, contrast free functional renal MRI scans. This study aims to use Non-invasive MR Imaging of Renal Physiology and structure to assess patients with Acute Kidney Injury (AKI) and Chronic Kidney Disease (CKD).

RENA 4590 (ASCEND-ND)

NIHR Porfolio Study ID: 25950

A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents.

NURTuRE-CKD

NIHR Porfolio Study ID: 32351

Project website: https://www.nurturebiobank.org/

Chronic Kidney Disease (CKD) affects around 10% of the adult population and is associated with an increased risk of heart attack, stroke and end stage kidney disease (ESKD). 

This study aims to better predict who is most likely to progress to ESKD using previously identified risk factors and novel biomarkers in blood and urine samples, along with kidney biopsy tissue. Resources can then be directed to those most at risk of disease progression, while those at lower risk can be offered less frequent monitoring. People without CKD will be invited to take part as a control group, so that results of those with CKD can be compared to those without CKD.

HaemoDialysis Interventions to Reduce Multi-Organ Dysfunction (HD-REMODEL)

NIHR Porfolio Study ID: 34933

A randomized cross-over proof of concept study to compare the effects of standard dialysis and cool temperature dialysis on the heart, brain and kidneys. Participants shall be randomised to start on either conventional or thermocontrolled haemodialysis for six sessions of dialysis, then will crossover for another six sessions. Each participant will undergo MRI scans throughout the final dialysis session of each set of six.

23Na MRI in CKD

NIHR Porfolio Study ID: 36832

Most forms of magnetic resonance imaging (MRI) are based on the principle that  water molecules behave in a certain way when they are placed in strong magnetic field. Most tissues in the human body contain water but in different amounts and held in different arrangements; MRI takes advantage of this to generate images of different tissues. 

A new form of MRI has been developed, that is able to measure the behavior of sodium (Na) atoms, instead of water molecules. This allows MRI to measure the amount of sodium in different tissues of the body. In particular, this study aims to use 23Na-MRI to measure sodium content of skin, muscle and in the kidney and see how these measures relate to blood pressure and other markers of cardiovascular health.

23Na MRI in Hemodialysis

NIHR Porfolio Study ID: 38066

A new form of magnetic resonance imaging (MRI) has been developed that is able to measure the behaviour of sodium (Na) atoms, instead of water molecules. This allows MRI to measure the amount of sodium in different tissues of the body. Now that 23Na MRI has been established as a technique, we wish to establish whether it is useful in patients receiving haemodialysis for end stage kidney disease (ESKD). In particular, we aim to use 23Na-MRI to measure sodium content of skin and muscle and see how these measures relate to blood pressure and volume status.

RaDaR - National Studies of Rare Kidney Diseases

NIHR Porfolio Study ID: 6726

Project website: https://rarerenal.org/radar-registry/

A new form of magnetic resonance imaging (MRI) has been developed that is able to measure the behaviour of sodium (Na) atoms, instead of water molecules. This allows MRI to measure the amount of sodium in different tissues of the body. Now that 23Na MRI has been established as a technique, we wish to establish whether it is useful in patients receiving haemodialysis for end stage kidney disease (ESKD). In particular, we aim to use 23Na-MRI to measure sodium content of skin and muscle and see how these measures relate to blood pressure and volume status.

 

Reproductive Health

Current recruiting studies

Mechanisms underlying physiology and pathophysiology of pregnancy

NIHR Porfolio Study ID: 10671

This study aims to investigate the mechanisms underlying the maintenance of normal human pregnancy and how these are altered in disorders leading to preterm birth.  Patients undergoing normal delivery, caesarean section or hysterectomy are elegible to patricipate.

 

Respiratory

Current recruiting studies

EMBARC: European Bronchiectasis Registry

NIHR Porfolio Study ID: 18252

Project website: https://www.bronchiectasis.eu/registry

Bronchiectasis is an orphan disease, with few evidence based treatments and a lack of data regarding epidemiology, co-morbidities, pathophysiology, severity and prognosis. There have been few longitudinal or cross-sectional studies in bronchiectasis. To give truly meaningful and generalizable results, a longitudinal observational study of bronchiectasis would require to enrol several thousand patients, more than any one centre can enrol. EMBARC will create an open, pan-European registry of patients with non-CF bronchiectasis.

Screening of target genes for polymorphic variation

NIHR Porfolio Study ID: 2902

The aims of the study are to define the extent of polymorphic variation in genes whose products are, or may be, primary targets for treatment of patients with asthma, and to identify if this genetic variation contributes to disease severity or treatment response.

LungCAST

NIHR Porfolio Study ID: 9851

Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications in lung cancer but prospective, well-designed studies are lacking. 

This project is an observational cohort study recording clinical outcomes in smokers, never-smokers, and ex-smokers newly diagnosed with lung cancer. This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test (eCO).

 

 

Skin

Current recruiting studies

BSTOP: Bio-markers of systemic treatment outcomes in Psoriasis

NIHR Porfolio Study ID: 10646

The Biomarkers of Systemic Treatment Outcomes in Psoriasis study (B-STOP) is a non-commercial observational study, which seeks to identify and characterise biomarkers of response to systemic and biologic treatments for psoriasis.  

Patients suffering from severe psoriasis have a range of treatment options available to them. However response to these treatments can vary widely from patient to patient. The B-STOP study examines which gene(s) and other 'biomarkers' are important in determining good or poor responses to the drugs that are used to treat psoriasis. Once discovered, researchers can develop a genetic and biological blueprint of each patient to identify, which treatments are most likely to work, rather than the current approach which is 'try it and see'. 

Genes and Gene Function in Lipoedema

NIHR Porfolio Study ID: 30988

Lipoedema is a relatively rare condition which presents clinically with excessive abnormal fat deposition, typically affecting the legs but not the feet. The extra fat deposition results in heavy legs that are tender, painful and bruise
easily. Onset of lipoedema is usually at puberty or other times of hormonal change. 

This study aims to discover the genes that cause, or predispose to, lipoedema. This will increase our undersanding of the underlying cause.

APRICOT

NIHR Porfolio Study ID: 31343

Pustular psoriasis is a term used to describe a particular form of psoriasis that is characterised by sore, red skin covered in pustules. Sometimes it can be generalised meaning that it covers most or all of the skin surface. In this instance it can be life threatening. Most forms of pustular psoriasis just affect the hands and feet when it is called palmo-plantar pustulosis (PPP). Treatment options are limited and unsatisfactory; even the recent, 'biologic' treatments that have been developed for the common form of psoriasis (plaque psoriasis) are usually ineffective.

This study aims to accurately determine how well anakinra works in PPP using the gold standard of clinical trial design, namely randomised control trial (RCT). This RCT will be supported by laboratory based investigations designed to understand the role of IL1 in APP and explain exactly how anakinra works.

 

Stroke

Current recruiting studies

Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)

NIHR Porfolio Study ID: 31526

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening.

In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis.

CONVINCE-A randomised clinical trial of low dose colchicine for secondary prevention after stroke

NIHR Porfolio Study ID: 33929

To reduce the risk of another stroke, the standard care often includes medicine that slows clotting (e.g aspirin), reduces cholesterol (e.g statins), and lowers blood pressure. The purpose of this study is to compare an anti-inflammatory medication called colchicine used with standard treatment to standard treatment is no placebo medication.

Patients who have recently had a stroke or transient ischemic attack may be invited to take part in the CONVINCE Study.

Validation and Reliability testing of a Nurse Dysphagia Assessment

NIHR Porfolio Study ID: 34877

Nurses at Royal Derby Hospital, UK have been trained to use a comprehensive protocol based dysphagia assessment (Dysphagia Trained Nurse Assessment (DTNAx)) to assess all acute stroke patients on admission. This study aims to validate the tool by comparing it to the gold standard assessment - Videofluoroscopy and usual assessment by a Speech and Language Therapist. Inter-rater and intra-rater reliability will also be tested by comparing the assessment results of two different nurses or the same nurse.

Feasibility study of biofeedback in dysphagia therapy post stroke

NIHR Porfolio Study ID: 34883

This study will investigate the feasibility of delivering swallowing therapy using surface electromyography as a means of biofeedback to patients with dysphagia in the acute stroke setting. It will investigate trends in efficacy by comparing biofeedback therapy to usual care. The results will inform future dosing and efficacy studies.

LACI-2

NIHR Porfolio Study ID: 36168

About 35,000 people each year in the UK have a type of stroke, called ‘lacunar’ or ‘small vessel’ stroke, which is different to other common types of stroke and for which there is no proven treatment. 

Two drugs that are commonly used in other vessel diseases may help improve small vessel function and prevent worsening of brain damage. Patients that join the study will be allocated open label to one of a possible four options:

  • cilostazol only
  • isosorbide mononitrate only
  • both cilostazol and isosorbide mononitrate
  • neither drug

In the current phase, up to 400 patients aged over 30 years, diagnosed as having had a lacunar stroke.

RETAKE - Return to Work After Stroke

NIHR Porfolio Study ID: 37304

This study aims to improve rehabilitation services for people in employment who have had a stroke. It is hoped that this study will help to support people who have had a stroke in returning to work. No disadvantages or risks are expected. Any appointments are arranged at times to suit the participants.

Stroke survivors aged 18 and over who were employed at stroke onset and their carers (if applicable) can participate.

 

Surgery

Current recruiting studies

By Band Sleeve Study

NIHR Porfolio Study ID: 11911

Obesity is an increasing health problem in the UK and is predicted to worsen. There are many health problems associated with obesity including risk of diabetes, gallbladder disease, sleep problems, heart disease and arthritis. These health issues can shorten a person’s life expectancy, impair quality of life and increase the use of expensive health services. Current national guidelines to treat obesity recommend management of life-style changes as the initial treatment for people who are overweight. However, surgery is considered for the very overweight (morbidly obese) or for those remaining obese after trying other options. In the UK and worldwide the two most commonly performed operations are laparoscopic adjustable gastric banding (’BAND surgery’) and laparoscopic gastric bypass (’BYPASS’).

This study E108is a randomised trial with a recruitment target of 1341 patients in eleven hospitals and its aim is to compare the effectiveness, cost effectiveness and acceptability of BAND, BYPASS and SLEEVE surgery.

CReST2

NIHR Porfolio Study ID: 32120

The aim of this study is to assess whether covered stents used for palliative patients with obstructing colorectal cancer, will result in an improved Quality of Life when compared to uncovered stents.

The CIPHER Study - Phase B

NIHR Porfolio Study ID: 35821

The CIPHER study aims to establish the incidence of symptomatic and radiologically confirmed parastomal hernia (PSH) during a minimum of 2 years follow up. Additionally, CIPHER aims to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent PSH formation.

AES Study

NIHR Porfolio Study ID: 38509

This project will engage patients and staff in the following four-phase study to better understand how closely health
professionals adhere to management guidance for the use of anti-embolism (AE) stockings:

  1. Interview 20 patients, and 30 health professionals (regular prescribers of AE stockings) about their experiences and views on use of the stockings in acute care.
     
  2. Observe current practice to determine compliance with best practice guidance.
     
  3. Explore in depth 10 cases of stocking-related pressure damage to understand the relationship between practice and damage.
     
  4. Work with former patients and staff to co-design patient information and staff education. This group will also guide and plan a future implementation study for improved practice. We will also consider the possibility of innovative design of a new product that may change practice and patient experience of this intervention.