Faecal Immunochemical Tests (FIT) for Surveillance After Colorectal Cancer (CRC) Study
Recruiting · NCT06689293 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- Patients under the age of 18
- Patients unable to give valid informed consent
- Patients with a current ileostomy, or no remaining colon after their operation (patients with colostomy will not be excluded)
- Patients already diagnosed with recurrence of their colorectal cancer
Where it is running
1 location listed.
- Nottingham University Hospitals NHS Trust - Nottingham, United Kingdom