Using a fecal test to reduce unnecessary colonoscopies after polyp removal

Fecal Immunochemical Test for Post-polypectomy Surveillance to Reduce Unnecessary eNdoscopy (FIT2RUN Study)

This study is testing whether a simple stool test can help people with a history of polyps or family history of colorectal cancer avoid unnecessary colonoscopies.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: University of Calgary (Academic / other)
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT05396560 on ClinicalTrials.gov

What this trial studies

This observational study aims to estimate the prevalence of advanced colorectal neoplasia in patients with a history of polyps or family history of colorectal cancer. It will evaluate the performance of Fecal Immunochemical Tests (FIT) as a potential alternative to colonoscopy for ongoing surveillance. By developing a risk prediction model, the study seeks to guide the choice between FIT and colonoscopy, addressing the growing demand for colonoscopy resources. The goal is to improve access to colonoscopy while reducing costs associated with surveillance.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 74 or younger with a personal or family history of colorectal polyps or cancer.

Not a fit: Patients with known genetic syndromes, recent colonoscopy, or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive and more cost-effective method for monitoring patients at risk for colorectal cancer.

How similar studies have performed: Other studies have explored the use of FIT in colorectal cancer screening, showing promising results, but this specific application for post-polypectomy surveillance is less established.

Eligibility criteria

Inclusion Criteria:

1. Men or women age ≤ 74 years of age.
2. At least one risk factor for CRC that would generally lead to colonoscopy screening:

   1. Personal history of low risk polyps
   2. Personal history of high risk polyps
   3. Family history of CRC or polyps

Exclusion Criteria:

1. Known acromegaly, cystic fibrosis or high risk profession (firefighter)
2. Referred for colonoscopy due to a positive fecal immunochemical test or CT colonography
3. Known or suspected gene carrier for a familial cancer syndrome.
4. Does not meet medical criteria for colonoscopy at the CCSC.
5. Colonoscopy within the previous 30 months
6. Unable to provide written informed consent or complete questionnaires due to language barrier or other reasons.

Where this trial is running

Calgary, Alberta

• Forzani & Macphail Colon Cancer Screening Centre, University of Calgary — Calgary, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Robert Hilsden, MD PhD — University of Calgary
• Study coordinator: Robert Hilsden, MD PhD

Conditions Colorectal Neoplasms