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

NCT06689293 | Recruiting

• 1 other identifier: 22CR002
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer (CRC)

Keywords

colorectal; Faecal Immunochemical Testing (FIT); surveillance

Outcome Measures

Primary Outcomes (1)

• 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

  Surveillance colonoscopy within 3 months of FIT sample

Secondary Outcomes (2)

• Low-risk polyps or inflammatory bowel disease

  Surveillance colonoscopy within 3 months of FIT sample

• Demographics of those not returning a FIT prior to surveillance colonoscopy

  Surveillance colonoscopy within 3 months of FIT sample

Study Arms (1)

Study group

Participants aged over 18 with previous colorectal cancer resection for curative intent, excluding those with current ileostomy or recurrent cancer.

Diagnostic Test: Faecal Immunochemical Test

Interventions

Faecal Immunochemical Test DIAGNOSTIC_TEST

Self-collected sample from stool collected into testing kit

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 \[NGHT\].

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

David J Humes

CONTACT

0115 951 5151; david.humes@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 23, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

GB (1)