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

Study acronym: FITS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 2024 to Feb 28, 2025
    • Study sites: 0 to 1
    • Primary completion date: Nov 1, 2026 to Feb 2027
    • Study completion date: Nov 1, 2026 to Jun 23, 2027
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06689293
Lead Sponsor Nottingham University Hospitals NHS Trust
Conditions
(from sponsor)
Colorectal Cancer (CRC)
Related terms Colorectal Neoplasms
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov