Enroll-HD is a prospective observational multicentre multi-national cohort study to be conducted in multiple native languages. Study visits will take place yearly and may occur at the time of the participant’s routine clinical care visit, where possible. The goal of Enroll-HD is to build a large and rich database of clinical information and biospecimens that will serve as a basis for future studies aimed at developing tools and biomarkers for progression and prognosis, identifying clinically relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies.

Principal Investigator: Dr Elizabeth Couthard
Planned End Date: Open ended
Local Ref: 3553

Enroll-HD (study explained above) is also a clinical research platform that supports other HD studies. Anyone participating in Enroll-HD study who have been confirmed to have the HD gene expansion are invited to take part in HDClairity.

HDClarity is looking at the biomarker, Cerebrospinal fluid (CSF). A biomarker is a biological measure that captures what is happening in a cell or organism at that given moment. These play an important role in understanding biological processes and understanding relationships between environment exposure, human biology and disease. CSF is an extremely useful biosample since it directly surrounds the brain and so likely reflects what is happening there throughout the course of disease. HDClarity is an open-ended study (no set end date) with CSF collection encouraged every year.
 

Principal Investigator: Dr Elizabeth Couthard
Planned End Date: 01/04/2026
Local Ref: 3817

European project title European eHealth Care Model for Rare Neurodegenerative Diseases: Development of HD-specific outcome measures UK study title Development and validation of multilingual, multinational HD specific need-based quality of life assessment tools: HD value assessment study.

This study is for anyone who is HD gene positive or companions of an individual who is HD gene positive. The aim is to find out more about their wishes, needs and expectations about living with Huntington’s Disease. From this, a questionnaire will be developed that can assess the quality of life for other individuals impacted by HD, in other countries too. 

PI : Ms Natalie Rosewell

Planned end Date: 01/09/2023

Local Ref: 4950
 

Longitudinal Adaptive Study of Molecular Pathology and Neuronal Networks in Huntington’s Disease Gene Expansion Carriers (HDGECs) and Healthy Controls using Positron Emission Tomography and Multi-modal Magnetic Resonance Imaging

Anyone participating in Enroll-HD study who has been confirmed to have the HD gene expansion are invited to take part in iMarkHD.

The study will compare PET and MRI scan measurements at different stages of the disease, with healthy control participants. This will look for changes which may influence the development of symptoms and disease progression. It may also lead to the identification of disease progression markers that characterise and predict symptom development which may be used in the future as outcome measures
 

PI: Dr Elizabeth Coulthard

Planned end date: 30/09/2024

Local Ref: 5213

​​​​​DRN 552 is a database collecting data from newly diagnosed patients with Type 1 diabetes, which may lead to progression onto other studies. It will characterisation of people with new-onset Type 1 diabetes (<6 months duration) and their siblings who are free from diabetes, with participants providing their consent to be contacted about other Type 1 diabetes research.

Project Details
Principal Investigator: Dr Danijela Tatovic
Planned End Date: 31/12/2022
Local Ref: 2969

This study aims to evaluate the decline in endogenous insulin secretion (measured using C-peptide) in a robustly defined cohort with Type 1 diabetes. We will recruit 164 participants who have been clinically diagnosed with Type 1 diabetes in the previous 100 days (113 diagnosed at over 30 years of age and 51 diagnosed at age 18-30 years). At the baseline visit we will take blood tests and perform a mixed meal tolerance test (repeat blood sampling after consumption of a liquid meal replacement). We will also ask volunteers to be fitted with a continuous glucose monitor to measure a participant’s daily glucose. This is a device worn on the upper arm and remains in place for 14 days.

We will repeat this mixed meal tolerance test after 6 months and 1 year to examine how quickly participant’s insulin secretion falls as well the continuous glucose monitoring.

We will also ask volunteers to do a home dried blood spot test (DBS) to measure insulin secretion at their own homes at baseline, 3, 6, 9 and 12 months. This is to see if a simple test which participants can do at home can be used to easily identify those with rapidly decreasing insulin secretion. We will compare how quickly participants lose their own insulin secretion in each age group and also examine how we can best identify older participants who will rapidly progress.

Project Details
Principal Investigator: Dr Angus Jones
Planned End Date: 31/12/2022
Local Ref: 4627

This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 27 academic institutions, 4 industrial partners, a small sized enterprise and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes".

The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and the UK, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with Type 1 Diabetes and their families.

Type 1 diabetes (T1D) occurs when a person's own immune system attacks their insulin producing cells. When newly diagnosed, many T1D patients still have 10-20% of their insulin-producing cells still functioning. The study is a multicentre, randomized, double-blind, placebo-controlled study in volunteers with newly diagnosed diabetes mellitus type 1 (within 6 weeks after diagnosis).

The purpose of the clinical trial (Ver-A-T1D) is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg) on the preservation of beta-cell function measured as stimulated C-peptide after 12 months compared to placebo.

The study has a cross-over design and a duration of approximately 24 months, consisting of 3 telephone visits and 7 visits at the trial site. The duration of the treatment phase with verapamil is 12 months, and an additional (optional) follow-up visit will be carried out 12 months after completion of the study. The study procedures are identical in all 20 clinical centres across Europe and the UK.

Project Details
Principal Investigator: Prof Colin Dayan
Planned End Date: 31/05/2023
Local Ref: 4680

ONWARDS 6 is a clinical study seeking to compare a new weekly insulin, insulin icodec, and a known insulin, insulin degludec, both in combination with mealtime insulin in people with Type 1 diabetes.

This is an international study of around 580 people in approximately 12 countries around the world. It is expected that about 45 participants will be from the United Kingdom.

Project Details
Principal Investigator: Dr Georgina Russell
Planned End Date: 28/10/2021
Local Ref: 4936

Bariatric surgery has substantial evidence demonstrating its safety and efficacy as a treatment for obesity and type 2 diabetes mellitus. However, there are a proportion of patients who do not demonstrate an improvement in diabetes control and another subset who will see the metabolic effects of surgery diminish with time. This study aims to see if continuing intensive multimodal therapy for type 2 diabetes mellitus following surgery would be beneficial in improving long term outcomes.

Participants will be followed up at 4 weeks, 3, 6, 12 months and then yearly thereafter for 5 years, medications will be titrated to help participants achieve targets for HbA1c, blood pressure and cholesterol levels.

Project Details
Principal Investigator: Dimitri Pournaras
Planned End Date: 01/10/2026
Local Ref: 4868

The study aims to assess risk and identify (if any) medication classes and/or individual medications for which absorption is likely to be significantly altered post-surgery, as well as determining medication information needs in this population.

Project Details
Principal Investigator: Danielle Wigg
Planned End Date: 14/06/2023
Local Ref: 5021

The profound improvement in glucose control after Roux-en-Y-gastric bypass (RYGB) has led to the recognition of the intestine as a major player in glucose regulation. The optimal length of each of the three limbs (alimentary, biliopancreatic and common) remains controversial. This is further complicated by the differences in total small intestinal length in humans (ranging between 3.5-10.5 meters).

Anatomical arrangements of RYGB results in three segments or 'limbs':

• Alimentary limb: Through which food enters the small intestine through a gastric pouch (the remnant of the stomach)
• Biliopancreatic limb: Includes the bypassed segments of the duodenum (first section of the small intestine) and proximal jejunum (second section) through which the biliopancreatic (bile acids from the gall bladder and pancreatic) secretions flow and
• Common limb: In which the food and biliopancreatic secretions mix.

Current evidence supports the hypothesis that a 'modified' RYGB with a long alimentary limb and short common limb may optimize glucose control. There have not been any clinical trials comparing 'modified' and 'standard' RYGB with glucose control as primary outcome.

In this study, we propose to recruit 80 patients with type 2 diabetes mellitus (DM) and obesity who are eligible for metabolic surgery and currently on the waiting list for bariatric surgery at North Bristol NHS Trust obesity service. Randomisation will take place intra-operatively in patients with a total small intestinal length < 5.5 meters. The surgeon will contact the randomiser who will make the allocation to either 'modified' or 'standard' RYGB before continuing with the surgery.

Participants will attend 5 visits in total (baseline, day 10, 3, 6 and 12 months post operatively) for anthropometric measurements, blood tests, urine pregnancy test, assessment of number of glucose lowering medications and adverse event profile.

Project Details
Principal Investigator: Dimitri Pournaras
Planned End Date: 01/06/2022
Local Ref: 5007

The metabolomics study aims to find out the impact of weight change and bariatric surgery on the levels of certain blood components.  The study involves donating a small sample of blood before your surgery and again one year later. Your blood samples will be used to measure changes in specific blood components after surgery and during weight loss.

Project Details
Principal Investigator: James Hopkins
Planned End Date: 01/03/2023
Local Ref: 4096

The sunflower study is for people who have gallstones. Some patients who are waiting for gallbladder surgery may also have gallstones that have moved into the bile duct. Currently, it is uncertain whether testing for bile duct stones, by doing an additional scan, is necessary. This study will find out whether it is necessary to test for bile duct stones in patients waiting for gallbladder surgery. By following up operation outcomes using medical notes, this study will compare what happens to patients who are tested for bile duct stones with patients who are not.

Project Details
Principal Investigator: James Hopkins
Planned End Date: 30/11/2022
Local Ref: 4262

A groundbreaking research study exploring the potential of blood tests to diagnose dementia is underway at North Bristol NHS Trust, marking a significant step toward improving the UK’s dementia diagnosis rate.

This initiative, led by the READ-OUT (REAl World Dementia OUTcomes) research team at Dementias Platform UK (DPUK), seeks to address gaps in diagnosis and enhance early detection of dementia, ultimately improving outcomes for people living with the condition.

The study is part of the Blood Biomarker Challenge – a multi-million-pound programme led by Alzheimer’s Society and Alzheimer’s Research UK, supported with funds raised by players of People’s Postcode Lottery. It aims to explore whether a panel of blood tests can complement existing diagnostic pathways in NHS memory clinics, helping clinicians provide faster and more accurate diagnoses for people living with dementia.

The team will assess multiple new and existing blood tests, looking at a range of dementia types including Alzheimer’s disease, vascular dementia, frontotemporal dementia, and dementia with Lewy bodies. The researchers will also look at whether the blood tests can help detect these diseases at various stages and if the results need to be interpreted differently in people from different ethnic backgrounds or with other health conditions such as kidney disease.

The first participants joined the study in Oxford in January 2025, marking the start of a nationwide drive to recruit over 3,100 participants from currently 31 DPUK sites across the UK. These sites, located in NHS memory clinics and community buses, aim to recruit participants from a diverse range of communities, ensuring the research is inclusive and reflects the wider population.

This research will provide vital evidence needed to integrate blood tests into routine clinical practice in the NHS, ultimately improving diagnosis speed and accuracy, and ensuring that more people in Bristol and across the UK receive timely treatments and support.

For more information on READ-OUT or to register interest in taking part in the study, visit the READ-OUT study site.

PI: Professor Elizabeth Coulthard

Planned end date: 31/10/2029

Local Ref: R&D 5727

COmBining memantine and cholinesterase inhibitors in Lewy body dementia Treatment trial

The COBALT Trial aims to find out if adding Memantine to AChEI treatment improves overall health and functioning for people with Lewy Body Dementia (DLB) or Parkinson's Disease Dementia (PDD).
A 150 patients with DLB and 150 patients with PDD, from across the UK will  take part in this trial. Participation will consist of a few visits over 52 weeks to the site for cognitive assessments, telephone follow ups and monitored use of either the placebo or Memantine. 

PI Dr Elizabeth Coulthard

Recruitment end date:01 April 2025

Local Ref: R&D 5195

Our research group and others have found links between Alzheimer’s and gum disease. Gum disease occurs when certain bacteria thrive under the gum line causing inflammation and bleeding. There is good evidence these bacteria pass into the bloodstream and speed up, or cause development of other diseases (such as diabetes and heart disease). This study monitors Alzheimer’s patients treated for gum disease for 12 months to see if this also slows their rate of memory loss. We're looking for 50 participants. 

PI: Dr Elizabeth Coulthard

Planned end Date: May 2025

Local Ref: R&D 5319

Perioperative Quality Improvement Programme: Patient Study

Over ten million operations take place in the UK NHS every year. The number of patients which are at high risk of adverse postoperative outcomes has grown substantially in recent years: this is attributable to a combination of an ageing population, the increased numbers of surgical options available for previously untreatable conditions, and the increasing numbers of patient presenting surgery with multiple comorbidities. Estimate of inpatient mortality after non-cardiac surgery range between 1.5 and 3.6% depending on the type of surgery and patient related risks. Major or prolonged postoperative morbidity occur in up to 15% of patients, and is associated with reduced long-term survival and worse health-related quality of life; this signal has been consistently demonstrated across different types of surgery, patient and healthcare systems.

This study will gather and analyse patient data for the newly established National Perioperative Quality Improvement Programme. PQIP will measure complications and outcomes from the patient perspective after major surgery. Patients will be approached at random, in participating hospitals, to give consent to have their data collected and used for research. The data collected will include information about patients, the surgery that they undergo, and the care that they receive.

The study aim is to comprehensively measure, report and improve risk-adjusted outcome from major surgery in the United Kingdom.

Chief Investigator – Professor SR Moonesinghe

Principal Investigator – Sarah Martindale

As anaesthetists, one of our primary roles is maintaining the patient’s airway during anaesthesia. Very rarely (1/50,000 anaesthetics) an anaesthetist is unable to either insert one of these tubes or provide oxygen to the patient in any other way which may result in brain damage due to harmfully low oxygen levels (hypoxia) or death. The solution to these situations, involves accessing the airway through an incision in the front of the neck (emergency Front of Neck Airway).

All anaesthetists are taught the practical steps involved, and the procedure itself is relatively easy to perform. Delay in making this decision is often the most common problem, yet very little research has been done examining the actual decision making required to perform this life saving procedure.

The aims of this study are to:

• Understand the thought process undergone by professionals needing to perform this task
• Identify reasons for any delay in making this decision

An experienced psychologist will carry out confidential semi-structured interviews with individuals whom have performed or attempted this emergency procedure within the past 2 years. It is hoped that the reasons why anaesthetists are reluctant to make this lifesaving decision could be elucidated. In doing so, these factors could be addressed in education and training of the workforce with the ultimate intention of making airway management and therefore anaesthesia safer for all patients.

Project Details
Principal Investigator: Dr Lawrence Kidd
Planned End Date: 01/05/2022
Local Ref: 4675

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.

Project Details
Principal Investigator: Mrs Sarah Martindale
Planned End Date: 31/10/2023
Local Ref: 3952

Characterising risk and biology Of Smouldering Myeloma for early detection Of Symptomatic myeloma

Study Overview: COSMOS is an observational study which means that there is no drug being tested. You will continue to be followed up regularly by your haematologist in clinic as normal. When you have a blood test or bone marrow test, we will use part of the sample for the study.

For more detailed information please visit the  COSMOS Trial website.

Principal Investigator: Alastair Whiteway 
Planned end date: 30/04/2027
Local Ref: 5754

MITHRIDATE: A phase III, randomised, open-label, Multicenter International Trial comparing ruxolitinib with either HydRoxycarbamIDe or interferon Alpha as first line ThErapy for high risk polycythemia vera

To see more detail about this study please visit  Mithridate - University of Birmingham who are sponsoring this study.

Study Overview: The MITHRIDATE study has been set up to investigate which treatment is most effective for patients who have high risk polycythemia vera (PV). The study will test how safe and effective a drug called ruxolitinib is when treating patients with PV compared to the current Best Available Therapy (BAT).

Principal Investigator: Alastair Whiteway
Planned end date: 01/07/2029
Local Ref: 5188

RADAR (UK-MRA Myeloma XV) is a clinical trial for newly diagnosed multiple myeloma patients who are suitable for a stem cell transplant. The trial will investigate precision medicine approaches to allocate treatment to patients based on the genetics of their myeloma and the patient’s response to initial treatment. Some patients have been found to have particular genetic abnormalities in the myeloma cells, and these ‘high risk’ patients do not respond well to standard treatment. It has also been found that some patients who don’t have these genetic abnormalities (‘standard-risk’) may not respond to initial therapy as well as others. This study will investigate treatment combinations for these two groups of patients. This study will also investigate whether a third group of patients, those who are standard-risk and also respond well to initial treatment, can receive treatment for a shorter period of time without coming to any harm.

Project Details
Principal Investigator: Dr Alastair Whiteway
Planned End Date: end 2025
Local Ref: 3959

STATIC

A Randomised Phase III Trial Comparing Intermittent with Continuous Treatment Strategies in Chronic Lymphocytic Leukaemia (CLL)

For more detailed information please visit the   STATIC Clinical Trial • CTRU Leeds Research Portal 

Study Overview: STATIC is a clinical trial to find out whether people with Chronic Lymphocytic Leukaemia (CLL) who have had a good response to ibrutinib or acalabrutinib can take a break from treatment, and only restart treatment if the CLL comes back. Therefore, we are comparing whether having a break from treatment with ibrutinib or acalabrutinib will work as well as continuing treatment without a break.

We will also test whether taking a break from treatment reduces side effects, whether it lowers the risk of CLL becoming resistant to ibrutinib or acalabrutinib, and whether there is any difference in the overall cost of CLL treatment. We also want to know whether having a break from ibrutinib or acalabrutinib changes how participants are feeling emotionally, and what they like and do not like about having treatment which includes breaks.

Principal Investigator: Dr Jaroslaw Sokolowski
Planned end date: 01/05/2032
Local Ref: 5122

Currently benign and malignant brain tumours are treated by surgery or radiation therapy plus or minus chemotherapy. The aim of the study is to discover and validate new molecular biomarkers and drug targets for brain tumours using laboratory research and comparing the findings with control tissue.

This includes also using tissues, blood fractions and cell culture from patients with brain tumours. We hope that in vitro research will reveal biomarkers for these tumours which in the future could indicate successful drug action or are specific for a genetic subtype of tumour. In addition, we hope that these biomarkers could aid early diagnosis of central nervous system (CNS) tumours.

Project Details
Principal Investigator: Dr Kathreena Kurian
Planned End Date: 20/07/2024
Local Ref: 4626