Trial Details

Recruiting
Basic Information
Clinical ID c2277
Identifier ISRCTN65030013
Trial Title Therapy Personalisation using Multiomic Analyses in Inflammatory Bowel Disease THAMES-IBD
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Inflammatory Bowel Disease Digestive System Crohn's disease, ulcerative colitis
Interventions This will be a prospective, multi-site observational cohort study, in order to gain real world evidence that is then applicable to standard practice across a range of institutions. All patients who are beginning work-up (including endoscopy) to start a new biologic because of active IBD, both biologic-naïve and biologic-experienced patients, will be considered. Regarding endoscopic biopsies, the non-IBD patients will be those undergoing endoscopy for other indications, e.g. polyp surveillance, lower gastrointestinal symptoms, anaemia, bowel cancer screening (noting that some trusts do not permit research biopsies to be taken during cancer screening). Minimally invasive biological samples will also be taken from participants with/without active IBD, such as blood, urine and stool, as control samples, with appropriate consent. After this, no further participation from control patients will be required. Their samples will be processed in the laboratory and analysed in the same way as the IBD patients' samples, and used to compare with the IBD samples. Patients with active IBD will be recruited, along with those with quiescent IBD and non-IBD patients, who will act as controls. A participant with active IBD will be required to provide different samples. Most of the procedures are part of standard clinical care, but extra material will be taken for research purposes. Depending on the scheduling of these tests, the order may be different for each patient. Local clinical and research teams will coordinate sample collection. Patients can still be enrolled and continue within the study if they cannot provide all of the samples, because of individual preference, logistical reasons at specific research sites, or because it would involve an invasive procedure that is not cli
Participant Information
Sponsor Imperial College London
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2027-12-01