ENDCaP-C test accuracy study

Plain English summary of protocol

Background and study aims
Ulcerative colitis (UC) is a long-term condition where the colon and rectum become inflamed. It 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.

Who can participate?
This study aims to recruit up to 1000 patients across NHS hospitals in the UK that have active long-term inflammatory bowel disease endoscopic surveillance programmes. Eligible patients will have UC (either for at least 10 years with extensive disease, or also have primary sclerosing cholangitis), will be on the surveillance programme and undergoing a routine colonoscopy during the study period, have no previous history of colorectal cancer and meet the rest of the rest of the eligibility criteria.

What does the study involve?
All patients will undergo a routine surveillance colonoscopy. In addition to the routine biopsies, an additional five biopsies will be taken. If cancer or the early stages of cancer are detected, 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 4 to 12 months. Patients will be followed up through routinely collected data sources, to include, for example, cancer development and long-term survival.

What are the possible benefits and risks of participating?
There may be no direct benefit in taking part in this study, however, participants may benefit from that any pre-cancer changes will be detected early which would ensure that treatments could be started earlier. It has been shown that starting treatment earlier is often more effective. The study may involve an extra colonoscopy between 6 and 9 months after entry into the study. This will involve standard bowel preparation (including laxatives or an enema). A sedative and pain killers may also be given during the colonoscopy. The procedure will be of roughly the same duration as the initial colonoscopy. There is a very small risk (a 1 in 1000 chance) with colonoscopy of bowel perforation or bleeding. If this happened, an operation would be required to repair the hole. At the second colonoscopy you will also be asked to provide a stool sample and to collect a small blood sample.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
From November 2014 to May 2018

Who is funding the study?
NIHR Efficacy and Mechanism Evaluation (UK)

Who is the main contact?
Dr Steve Johnson
As of 10/02/2017: Laura Magill

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/05/2018: The following changes have been made:
1. The publication and dissemination plan has been changed.
2. An intention to publish date has been added.
21/05/2018: The following changes have been made:
1. The interventions have been changed.
2. The primary outcome measures have been changed.
3. The overall trial end date has been changed from 31/12/2017 to 31/05/2018.
4. The participant inclusion criteria have been changed.
5. The participant exclusion criteria have been changed.
6. The plain English summary has been changed to reflect the changes above.
10/02/2017: Overall trial end date changed from 30/04/2016 to 31/12/2017. Recruitment end date changed from 30/04/2016 to 31/03/2017. Alexandra Hospital (UK), Southampton General Hospital (UK) and Norfolk and Norwich University Hospital (UK) were removed as trial participating centres. Basildon University Hospital, Whipps Cross University Hospital, James Cook University Hospital, Hull Royal Infirmary, Princess Alexandra Hospital, North Tyneside General Hospital, Darlington Memorial Hospital, Kettering General Hospital, King's Mill Hospital, Luton and Dunstable University Hospital, St Mary's Hospital (Paddington), Queen Elizabeth Hospital (Gateshead) were added as trial participating centres. Internal review was conducted.