ENDCaP-C Test Accuracy Study
Research type
Research Study
Full title
Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis (ENDCaP-C) A Multicentre test accuracy study
IRAS ID
164021
Contact name
Laura Magill
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
Ulcerative colitis (UC) affects over 30,000 patients in the UK and patients with long-term UC are at an increased risk of developing bowel cancer.
Timely recognition of the development of cancer is vital in order to improve outcome for patients. Currently in the UK, patients undergo regular and thorough surveillance of the colon to look for the early signs of cancer. Unfortunately this is not adequate and the mortality from late-detected colitis associated cancers remains high.
The main aim of this study is to evaluate the ability of a new diagnostic test to detect patients at high risk of developing colon cancer compared to histology.
The test is based on determining whether certain genes that protect against the development of cancer have been inactivated and if effective, could result in a significant change in practice.Eligible patients will have had a diagnosis of UC for at least 10 years, will be scheduled for surveillance colonoscopy during study period, have no previous history of colorectal cancer and meet the rest of the rest of the eligibility criteria.
This study aims to recruit 1000 patients across a minimum of 8 NHS hospitals in the UK that have active long-term inflammatory bowel disease endoscopic surveillance programmes.
The ENDCaP-C study will last for a total of 6 months for each patient, consisting of an initial colonoscopy and biopsy. If cancer, or the early stages of cancer are detected by either method, then the patient will be offered surgery. Patients for which the new test detects cancer, but histology does not will undergo a repeat colonoscopy at 6 months.
The end of the study as a whole will be once the last participant has reached 6-month follow-up. Patients will be followed up through routinely collected data sources, to include, for example cancer development and long term survival.
REC name
London - Surrey Research Ethics Committee
REC reference
14/LO/1842
Date of REC Opinion
16 Oct 2014
REC opinion
Favourable Opinion