Trial Details

Recruiting
Basic Information
Clinical ID c2037
Identifier ISRCTN12203379
Trial Title Cellular and molecular profiling of human primary sclerosing cholangitis (PSC)
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Primary sclerosing cholangitis Digestive System
Interventions This is a single-centre cross-sectional observational cohort study with sample and data collection taking place in line with the routine standard of clinical care visits. Participants eligible for the study will be identified through specialist liver and gastroenterology clinics, including endoscopy lists, at University Hospitals Birmingham. Participants will be approached during their routine clinic visit and once consented will be sent a patient information sheet and invitation letter to participate in this study. After signing an informed consent form, investigators will complete a case record form together with the participant, detailing the minimum required dataset pertaining to medical background, disease activity and severity, treatment regimens and routinely collected clinical, laboratory and radiological information. Routine samples will be obtained at the same time as routine standard-of-care hospital visits. Samples will include peripheral blood, stool, colonic biopsies and biliary biopsies or aspirates. All samples will be processed in line with sample-specific protocols. The minimum sample set per patient is blood and stool samples, in addition to colonic samples for those with primary sclerosing cholangitis and concomitant inflammatory bowel disease. No long-term follow-up data will be collected from any of the study participants. The total number of participants across all aetiologies will be approximately 350; however, it is intended that a single patient is eligible to donate more than one sample type. The total number of participants will be dictated by the number required to meet the target sample size for each sample subgroup as per the following breakdown: Peripheral Blood: PSC=100 IBD alone=100 Healthy controls=50 Primary biliary chol
Participant Information
Sponsor University of Birmingham
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 2026-10-15