NCT06898996Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The purpose of this clinical study is to evaluate the accuracy of the fecal immunochemical test (FIT) in comparison to colonoscopy in patients with Lynch Syndrome (LS) who are undergoing colonoscopy surveillance.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 20 Mar 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 1 Mar 2029
- Lead sponsor
- University of Chicago
- Diseases
- Colorectal cancer
- NCT number
- NCT06898996
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 10 Jul 2025 to the primary completion date, 1 Mar 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who have previously undergone a subtotal or total colectomy.
Other illness
- Individuals with inflammatory bowel disease or active malignancy.
Age
- Newly diagnosed Lynch Syndrome patients \< 20 years old with a pathogenic variant in MLH1, MSH2 or EPCAM, MSH6 or PMS2.
- Newly diagnosed Lynch Syndrome patients \< 30 years old with a pathogenic variant in MSH6 or PMS2.
Other
- Individuals who have not proceeded with genetic testing and therefore are not known to have LS, despite family history and/or criteria for testing.
- Individuals who are pregnant.
- Individuals not willing or able to sign informed consent.
Who the study is looking for
- Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
- Aged 20 - 80 years (for those with pathogenic variants in MLH1, MSH2, and EPCAM)
- Aged 30 - 80 years (for those with pathogenic variants in PMS2 or MSH6).
- Have an upcoming standard of care (SOC) colonoscopy appointment in line with standard LS surveillance guidelines (NCCN).
- Patients with previous colon surgery who still have 20cm or more of colon remaining
- Patients who are diagnosed with advanced neoplasia (e.g., advanced adenomas or cancers) and have NOT had endoscopic or surgical resection
- Willing to sign informed consent, collect stools samples and complete surveys
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| The University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.