Giant Cell ArteritisNCT04102930
Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by University of Leeds at 76 sites in United Kingdom.
Trial summary
A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis, Polymyalgia Rheumatica
- How many people
- 4,500 participants
- Where
- 76 sitesUnited Kingdom
- Study dates
- 10 Jun 2005to 31 Mar 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients predominantly recruited from secondary but can be identified and/or recruited in primary care.
Who may be able to join
- Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.
- Have a firm clinical diagnosis of GCA or PMR, or (for patients identified prospectively) GCA or PMR should be more likely than any alternative explanation for the patient's symptoms.
- Able and willing to give informed consent. Patients will be 50 years of age or over, unless both biopsy-proven and a clinically classical case of GCA.
Who cannot join
- Patient unwilling or unable to give fully informed consent.
Trial locations and contacts
76 sites in 1 country. Contact the study team or a site near you to ask about taking part.
76 sites in 1 country
United Kingdom76 sites, 62 recruiting
- Recruiting
Nevill Hall Hospital, Aneurin Bevan University Health Board
Abergavenny
Eleri Thomas
- Recruiting
Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
Aylesbury
Malgorzata Magiliano
- Recruiting
Betsi Cadwaladr University Health Board
Bangor, LL57 2PW
Subhra Raghuvanshi
Subhra Raghuvanshi
- Completed
Barnsley Hospital, Barnsley Hospital NHS Foundation Trust
Barnsley
- Recruiting
Basildon University Hospital, Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon
Anupama Nandagudi
- Recruiting
Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
Basingstoke
Emma Williams
- Recruiting
Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust
Bath
Sarah Skeoch
- Recruiting
Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham
Asad Khan
- Recruiting
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham
Susie Mollan
- Recruiting
Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust
Bristol
Jo Robson
- Recruiting
Queen's Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Burton-on-Trent
Ramasharan Laxminarayan
- Recruiting
West Suffolk Hospital, West Suffolk NHS Foundation Trust
Bury St Edmunds
Shweta Bhagat
- Recruiting
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge
Ei Phyu Htut
- Recruiting
Queen Elizabeth The Queen Mother Hospital
Canterbury, Kent, CT 1 3NG
Denise De Lord
- Recruiting
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
Chelsea
Amjad Jilani
- Recruiting
West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
Chelsea
Diana Davis
- Recruiting
Ashford and St Peter's Hospitals, Ashford & St Peter's Hospitals NHS Foundation Trust
Chertsey
Rod Hughes
- Recruiting
Countess of Chester Hospital, Countess of Chester NHS Foundation Trust
Chester
Deepti Kapur
- Recruiting
Christchurch Hospital, University Hospitals Dorset NHS Foundation Trust
Christchurch
Jonathan Marks
- Recruiting
Croydon University Hospital, Croydon Health Service NHS Trust
Croydon
Sarah Levy
- Recruiting
Darlington Memorial Hospital, County Durham and Darlington NHS Foundation Trust
Darlington
Nathan Rushby
- Recruiting
Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Derby
Azza Hussein
- Recruiting
Doncaster Royal Infirmary, Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster
Chee-Seng Yee
- Completed
Ninewells Hospital and Medical School, NHS Tayside
Dundee
- Recruiting
Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust
Exeter
Mahdi Abusalameh
- Completed
Frimley Park Hospital, Frimley Park Hospital NHS Foundation Trust
Frimley
- Recruiting
Gateshead Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust
Gateshead
Vadivelu Saravanan
- Completed
Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde
Glasgow
- Completed
Royal Alexandra Hospital, NHS Greater Glasgow and Clyde
Glasgow
- Completed
Vale of Leven Hospital, NHS Greater Glasgow and Clyde
Glasgow
- Completed
James Paget Hospital, James Paget University Hospitals NHS Foundation Trust
Great Yarmouth
- Completed
Royal Surrey County Hospital, Royal Surrey County Hospital NHS Foundation Trust
Guildford
- Recruiting
Harrogate and District Hospital, Harrogate and District NHS Foundation Trust
Harrogate
Andrew Gough
- Recruiting
Hull Royal Infirmary, Hull and East Yorkshire NHS Trust
Hull
Yusuf Patel
- Completed
Ipswich Hospital, East Suffolk and North Essex NHS Foundation Trust
Ipswich
- Recruiting
Airedale General Hospital, Airedale NHS Foundation Trust
Keighley
Shabina Sultan
- Recruiting
Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal
Marwan Bukhari
- Completed
The Queen Elizabeth Hospital, The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust
Kings Lynn
- Recruiting
Royal Lancaster Infirmary, University Hospitals of Morecambe NHS Foundation Trust
Lancaster
Marwan Bukhari
- Recruiting
Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust
Leeds
Sarah Mackie
- Recruiting
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester
Kehinde O Sunmboye
- Recruiting
Aintree University Hospital, Aintree University Hospitals NHS Trust
Liverpool
Robert Moots
- Recruiting
Royal Glamorgan Hospital, Cwm Taf University Health Board
Llantrisant
Ceril Rhys Dillon
- Recruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London
James Peters
- Recruiting
King's College Hospital, King's College Hospital NHS Foundation Trust, London
London
Eoin O'Sullivan
- Recruiting
Royal Free Hospital, Royal Free NHS Foundation Trust
London
Animesh Singh
- Recruiting
St George's Hospital, St George's University Hospitals NHS Foundation Trust
London
Nidhi Sofat
- Recruiting
University College London Hospital, University College London NHS Foundation Trust
London
Vanessa Morris
- Recruiting
Manchester Royal Infirmary, Manchester University NHS Foundation Trust
Manchester
Ben Parker
- Recruiting
Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust
Metropolitan Borough of Wirral
Emmanuel George
- Recruiting
Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Newcastle
John Isaacs
- Recruiting
North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust
North Shields
Ischmael Atchia
- Recruiting
Northampton General Hospital, Northampton General Hospital NHS Trust
Northampton
Pradip Nandi
- Completed
Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
- Recruiting
Queens Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham
Peter Lanyon
- Not yet recruiting
Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust
Oxford
Raashid Luqmani
- Recruiting
Peterborough City Hospital, North West Anglia NHS Foundation Trust
Peterborough
Poonam Sharma
- Recruiting
Derriford Hospital, University Hospital Plymouth NHS Trust
Plymouth
Jon King
- Recruiting
Poole Hospital, University Hospitals Dorset NHS Foundation Trust
Poole
Muhammad Khursid
- Recruiting
Whiston Hospital
Prescot, Merseyside, L35 5DR
Julie Dawson
- Recruiting
Minerva Health Centre, Lancashire and South Cumbria NHS Foundation Trust
Preston
Sarah Horton
- Recruiting
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Hedley Emsley
Anna Bhargava
- Recruiting
Salford Royal Hospital, Salford Royal NHS Foundation Trust
Salford
Sanjeet Kamath
- Recruiting
Scarborough General Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust
Scarborough
Zaid Al-Saffar
- Recruiting
Southend University Hospital, Southend University Hospital NHS Foundation Trust
Southend-on-Sea
Bridgett Masunda
- Recruiting
Lister Hospital, East and North Hertfordshire NHS Trust
Stevenage
Thiraupathy Marianayagam
- Recruiting
Haywood Hospital, Midlands Partnership NHS Foundation Trust
Stoke-on-Trent
Ajit Menon
- Recruiting
Great Western Hospital, The Great Western Hospitals NHS Foundation Trust
Swindon
David Collins
- Completed
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay
- Recruiting
Royal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust
Truro
David Hutchinson
- Recruiting
Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield
Chamila Hettiarachchi
- Recruiting
Warrington Hospital, Warrington and Halton Hospitals NHS Foundation Trust
Warrington
Hala Sadik
- Completed
Warwick Hospital, South Warwickshire NHS Foundation Trust
Warwick
- Recruiting
Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust
Winchester
Emma Williams
- Recruiting
University Hospital Wishaw, NHS Lanarkshire
Wishaw
James Dale
- Completed
York Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust
York
About this study
Official title: UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)
A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. A subset of the retrospective cohort is also enrolled in a post-marketing surveillance registry of patients eligible for, or receiving tocilizumab, to treat their relapsing or refractory GCA.
Read the detailed description
Giant cell arteritis (GCA), also known as temporal arteritis, is the most common form of primary systemic vasculitis, with up to 75,000 cases a year identified in the EU and US. It occurs almost exclusively in people over the age of 50 years and is considered to be a medical emergency. If not treated with high-dose glucocorticoids immediately, the thickening of the inflamed blood vessel wall can cause irreversible visual loss or stroke. GCA can lead to significant morbidity across a variety of systems, due to both the disease, and complications of treatment. Diagnosis may be confirmed with a temporal artery biopsy, imaging (e.g. USS/CT/MRA/PET-CR) or based on clinical signs (e.g. erythrocyte sedimentation rate) and symptoms (e.g. a new headache, jaw claudication, visual disturbances, temporal artery abnormality such as tenderness or decreased pulsation) .
Polymyalgia rheumatica (PMR) is characterised by inflammatory limb-girdle pain with early morning stiffness, and a systemic inflammatory response demonstrated by elevated inflammatory markers.
The UK GCA Consortium is a multi-centre observational study, the main arms of which recruit prospective (participants with suspected GCA) and retrospective cohorts (participants with confirmed GCA diagnosis). Analysis of data collected on these cohorts will help achieve the primary aim of finding genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. Secondary aims, and their associated analyses, are as follows:
- Phenotype: characterising GCA and PMR subtypes, based on clinical features; imaging; cells; subcellular fractions and molecules in the circulation and/or arterial tissue; genetic/epigenetic/transcriptomic/proteomic or metabolomics factors, including next generation sequencing (whole exome sequencing) of selected cases.
- Life impact: determining what aspects of the disease and treatments affect patients' quality of life, as assessed by patient-reported outcomes.
- Long-term outcomes: characterising prognosis of GCA and PMR - both effects of the disease and its treatment - by longitudinal follow-up through electronic linkage to health records.
- Exploratory analyses: exploring the potential role of environmental factors and co-morbidities on phenotype and outcomes.
- Diagnosis, prognosis: improving diagnosis of GCA and PMR, and identifying factors that predict diagnosis, such as diagnostic clinical features, and prognostic and diagnostic biomarkers.
- Disease activity: monitoring participants who commence a synthetic or biological disease-modifying anti-rheumatic drug (s/bDMARD). Finding a biomarker for GCA and PMR disease activity, which might be clinically useful in helping to optimise steroid and s/bDMARD treatments for individual patients.
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Medical subject headings
- Giant Cell Arteritis, Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | A patient who has a diagnosis of GCA or PMR | |
| Prospective | Patient with suspected GCA and PMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome for genetic susceptibility studies:
Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise.
Measured: At baseline
Secondary outcomes (7)
Phenotype
Clinical phenotype or subtype of GCA/PMR based on disease features and imaging undertaken as part of routine clinical practice, and on research tests, such as imaging performed for research purposes, cells, subcellular fractions and molecules in the circulation and/or arterial tissue and genetic/ epigenetic/ transcriptomic/ proteomic or metabolomic factors, including next generation sequencing (whole exome sequencing) of selected cases.
Measured: At baseline
Life impact questionnaires
Assessment of the impact the disease and treatment has on the patients' lives as reported by the patient
Measured: At baseline
Long term outcomes
Longitudinal follow-up of patients (as far as is possible from medical and electronic records and without requiring additional study visits) to define prognosis/disease outcomes, such as ischaemic manifestations, aneurysm formation, duration of steroid therapy, disease flares, complications related to steroid therapy.
Measured: At baseline
Diagnosis of GCA/PMR
Diagnosis in patients presenting with suspected GCA/PMR (prospective study).
Measured: Through study completion, an average of 1 year
Exploratory analyses
To investigate role of genetics, environmental factors (e.g. diet and sunlight) and co-morbidities (e.g. periodontal disease) on disease phenotype and outcome as assessed by the patient-administered questionnaires.
Measured: At baseline
Disease activity defined as an increase in clinical and patient reported activity of disease
Participants commencing a synthetic or biological disease modifying anti-rheumatic drug with or without additional steroid therapy will have their disease activity assessed.
Measured: At baseline
Proteomic and genomic analyses on serum, plasma and urine samples.
A variety of 'omic technologies will be applied to cell populations isolated from the blood and/or routine diagnostic arterial biopsies, including, but not limited to, RNASeq and a variety of proteomic approaches.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start10 Jun 2005
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,500 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Ann Morgan, University of Leeds
- Investigators
- Ann Morgan, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102930
- Sponsor's protocol ID
- MM05/7037
- Status last verified
- Mar 2025
- First submitted
- 30 Jul 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)
- ClinicalTrials.gov ID
- NCT04102930
- Acronym / sponsor ID
- MM05/7037
- Conditions
- Giant Cell Arteritis, Polymyalgia Rheumatica
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 10 Jun 2005 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. A subset of the retrospective cohort is also enrolled in a post-marketing surveillance registry of patients eligible for, or receiving tocilizumab, to treat their relapsing or refractory GCA.
Detailed description
Giant cell arteritis (GCA), also known as temporal arteritis, is the most common form of primary systemic vasculitis, with up to 75,000 cases a year identified in the EU and US. It occurs almost exclusively in people over the age of 50 years and is considered to be a medical emergency. If not treated with high-dose glucocorticoids immediately, the thickening of the inflamed blood vessel wall can cause irreversible visual loss or stroke. GCA can lead to significant morbidity across a variety of systems, due to both the disease, and complications of treatment. Diagnosis may be confirmed with a temporal artery biopsy, imaging (e.g. USS/CT/MRA/PET-CR) or based on clinical signs (e.g. erythrocyte sedimentation rate) and symptoms (e.g. a new headache, jaw claudication, visual disturbances, temporal artery abnormality such as tenderness or decreased pulsation) .
Polymyalgia rheumatica (PMR) is characterised by inflammatory limb-girdle pain with early morning stiffness, and a systemic inflammatory response demonstrated by elevated inflammatory markers.
The UK GCA Consortium is a multi-centre observational study, the main arms of which recruit prospective (participants with suspected GCA) and retrospective cohorts (participants with confirmed GCA diagnosis). Analysis of data collected on these cohorts will help achieve the primary aim of finding genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. Secondary aims, and their associated analyses, are as follows:
- Phenotype: characterising GCA and PMR subtypes, based on clinical features; imaging; cells; subcellular fractions and molecules in the circulation and/or arterial tissue; genetic/epigenetic/transcriptomic/proteomic or metabolomics factors, including next generation sequencing (whole exome sequencing) of selected cases.
- Life impact: determining what aspects of the disease and treatments affect patients' quality of life, as assessed by patient-reported outcomes.
- Long-term outcomes: characterising prognosis of GCA and PMR - both effects of the disease and its treatment - by longitudinal follow-up through electronic linkage to health records.
- Exploratory analyses: exploring the potential role of environmental factors and co-morbidities on phenotype and outcomes.
- Diagnosis, prognosis: improving diagnosis of GCA and PMR, and identifying factors that predict diagnosis, such as diagnostic clinical features, and prognostic and diagnostic biomarkers.
- Disease activity: monitoring participants who commence a synthetic or biological disease-modifying anti-rheumatic drug (s/bDMARD). Finding a biomarker for GCA and PMR disease activity, which might be clinically useful in helping to optimise steroid and s/bDMARD treatments for individual patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –A patient who has a diagnosis of GCA or PMR |
| Prospective | – | –Patient with suspected GCA and PMR |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients predominantly recruited from secondary but can be identified and/or recruited in primary care.
Key inclusion criteria (3 listed)
- Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.
- Have a firm clinical diagnosis of GCA or PMR, or (for patients identified prospectively) GCA or PMR should be more likely than any alternative explanation for the patient's symptoms.
- Able and willing to give informed consent. Patients will be 50 years of age or over, unless both biopsy-proven and a clinically classical case of GCA.
Key exclusion criteria (1 listed)
- Patient unwilling or unable to give fully informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome for genetic susceptibility studies:
Time frame: At baseline
Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise.
7 secondary outcomes
Phenotype
Time frame: At baseline
Life impact questionnaires
Time frame: At baseline
Long term outcomes
Time frame: At baseline
Diagnosis of GCA/PMR
Time frame: Through study completion, an average of 1 year
Exploratory analyses
Time frame: At baseline
Disease activity defined as an increase in clinical and patient reported activity of disease
Time frame: At baseline
Proteomic and genomic analyses on serum, plasma and urine samples.
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Morgan principal investigator
University of Leeds
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Polymyalgia Rheumatica, run by University of Leeds at 76 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Sorensen (0113 343 7764, MRCTarget@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome for genetic susceptibility studies: (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.