TrueColours Ulcerative Colitis Version 1.0
Research type
Research Study
Full title
TrueColours Ulcerative Colitis: A pilot study examining real time data collection in patients with ulcerative colitis
IRAS ID
185071
Contact name
Alissa J Walsh
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
Conventional management of ulcerative colitis focuses on assessment during brief clinic visits often weeks or months apart. Treatment decisions are often reactive and based on a sometimes inaccurate patient recall of events. There is a need to understand daily fluctuations in disease activity to facilitate disease control, which presents an opportunity to explore the biology of ulcerative colitis.
TrueColours Ulcerative Colitis is a technology which provides real time data collection whereby participants are prompted to enter daily symptoms and fortnightly quality of life scores. It also allows personalised questionnaires and home faecal calprotectin measurements (through integration with IBDoc). Blood, endoscopy and histological results will also be entered. All of this information is graphed and is accessible to both individual participants and to the TrueColours research team via password-protected access on an NHS server. Treatment guidance is given depending upon the daily symptom score. The pilot study will enrol 60 participants and follow them up for 6 months.
One aim of TrueColours Ulcerative Colitis is to align real time data collection with examining the biology of the disease. The goal is to examine pathways known to be of interest to the pathogenesis of UC as well as established or novel therapeutic targets. Re-identifiable blood samples and mucosal biopsies will be taken at scheduled intervals. Standard blood analysis will be performed. Blood will also be separated to generate peripheral blood mononuclear cells and plasma. Some whole blood will be used to make and store DNA. Standard biopsies will be scored for disease activity. For additional research biopsies, these will be taken, digested and most will be utilised within a week with no remaining material stored. In some cases biopsies will be fixed and stored for the duration of the study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0103
Date of REC Opinion
25 Mar 2016
REC opinion
Further Information Favourable Opinion