Faecal Immunochemical Tests (FIT) for Surveillance After Colorectal Cancer (CRC) Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

In the United Kingdom, over 25,000 patients have an operation for bowel cancer each year. After their operation, patients are monitored with a colonoscopy (camera test of the bowel) approximately 3 years after their operation, to look for any possible return of the cancer. Colonoscopies, and the bowel-cleaning medications needed, can be unpleasant for patients. The Faecal Immunochemical Test (FIT) is a test to look for blood hidden in the poo. Blood in the poo can be a sign of bowel cancer, or a growth that can turn in to a cancer if left untreated (polyps). We currently use this test for bowel cancer screening, and to assess the risk of cancer in patients with bowel symptoms. You may have had a FIT when having tests for bowel cancer. We know this test is effective in picking up bowel cancer in these cases, but its use has not been assessed in following-up patients who have had treatment for bowel cancer previously. For this study, we aim to see if a FIT stool sample test is accurate at diagnosing a return of bowel cancer for patients who have had a previous operation for bowel cancer. We want to see if using FIT could 'rule-out' cancer for some patients and be a potential alternative to colonoscopy for some patients in the future, allowing them to avoid this sometimes unpleasant test, which patient groups have told us is important for them. Patients taking part in this study will have their usual treatment, including their colonoscopy (or sometimes a scan of the bowel), but will be asked to also provide a single FIT sample to assess how accurate this test is. The FIT sample is a quick and easy test of the poo that you can take at home and send to Nottingham University Hospitals NHS Trust (NUH) for testing. It should take no more than 5 to 10 minutes to take the sample, and a prepaid envelope is included to send the sample back to NUH for testing. We aim to include at least 1,000 patients across 7 hospital trusts in the East Midlands.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Histological diagnosis of colorectal carcinoma

• Previously treated by surgical resection with curative intent for colorectal carcinoma

• Due whole-colon investigation for CRC follow-up as part of local routine care (Colonoscopy or CT colon)

Locations
Other Locations
United Kingdom
Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Contact Information
Primary
David J Humes
david.humes@nhs.net
0115 951 5151
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2027-06-23
Participants
Target number of participants: 1000
Treatments
Study group
Participants aged over 18 with previous colorectal cancer resection for curative intent, excluding those with current ileostomy or recurrent cancer.
Related Therapeutic Areas
Sponsors
Leads: Nottingham University Hospitals NHS Trust

This content was sourced from clinicaltrials.gov