Immuniverse
Research type
Research Study
Full title
ImmUniverse - Better control and treatment of immune- mediated diseases by exploring the universe of micro- environment imposed tissue signatures and their correlates in liquid biopsies
IRAS ID
311860
Contact name
Sreedhar Subramanian
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 11 months, 28 days
Research summary
Ulcerative colitis (UC) is a chronic inflammatory condition of the large bowel (colon) which often requires long-term treatments which suppress the immune system. For instance, patients are treated with biological drugs such as anti-tumour necrosis factor (TNF) agents (infliximab, adalimumab or golimumab) which target the inflammatory molecule TNF, anti-adhesion drugs such as vedolizumab which block the migration of inflammatory cells to the gut or ustekinumab, a drug which blocks the inflammatory proteins interleukins-12 and -23. Non-biological drugs such as tofacitnib which blocks inflammatory proteins are also used for treating UC. Response to these drugs is variable with typical response rates of approximately 50%. There are no clear indicators of which patient is likely to respond to one or the other class of biological agent making the choice arbitrary. Identifying accurate predictors has several advantages including avoidance of adverse reactions from unnecessary exposure to treatment, minimising time spent with active disease and, finally, cost-savings. Currently available predictive technologies have poor accuracy. In this multi-centre European observational study, we plan to systematically collect biological samples (blood, stool, colonic biopsies) from UC patients before they start treatment and at certain time points after they start treatment. If patients are switched over to another treatment due to lack of response, we will collect additional samples from these patients. Additional biopsies will be collected when the patients undergo a sigmoidoscopy test (limited camera examination of the bowel) as part of their standard clinical care.
REC name
London - City & East Research Ethics Committee
REC reference
22/PR/0815
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion