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.
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)
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
Eligible patients, due to have their 3-year postoperative surveillance colonoscopy/CTC, at each site will be invited to participate in the study. The colorectal cancer lead in each Trust has agreed to support the study and actively recruit from their site. Patients will be identified at each site by the clinical teams based there. Each trust has a locally managed electronic database used to manage surveillance scheduling of investigations for patients following CRC surgery. Participating Trusts include Nottingham University Hospitals \[NUH\], Royal Derby Hospitals \[RDH\], Chesterfield Royal Hospital Foundation Trust \[CRHFT\], Sherwood Forest Hospitals NHS Foundation Trust \[SFHFT\], United Lincolnshire Hospitals Trust \[ULHT\], University Hospitals of Leicester NHS Trust \[UHLT\] and Northampton General Hospital NHS Trust \[NGHT\].
Cohort
Prospective
Faecal Immunochemical Test
Diagnostic testSelf-collected sample from stool collected into testing kit
Recurrent colorectal cancer or high-risk polyps
Presence of colorectal cancer (recurrent) or high-risk polyp (\>10mm, high-grade dysplasia) at 3-year surveillance colonoscopy or CT colon
Low-risk polyps or inflammatory bowel disease
Low -risk (\<10mm) polyps or inflammatory bowel disease found at surveillance colonoscopy or CT colon.
Demographics of those not returning a FIT prior to surveillance colonoscopy
Age, sex, ethnicity and deprivation level (from first 4 characters of post code) compared between those returning and not returning a FIT.
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