RecruitingNCT06898996

FITting Non-invasive Tests in Lynch Syndrome Surveillance

FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study


Sponsor

University of Chicago

Enrollment

400 participants

Start Date

Jul 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether stool-based tests (specifically the FIT test — a fecal immunochemical test) can serve as a useful screening tool in between colonoscopy appointments for people with Lynch syndrome, a genetic condition that significantly increases the risk of colorectal cancer. Lynch syndrome requires regular colonoscopy surveillance, but researchers want to know if adding a simple stool test can help catch cancers or precancerous changes earlier, between those scheduled scopes. **You may be eligible if...** - You have a confirmed diagnosis of Lynch syndrome with a pathogenic (disease-causing) variant in the MLH1, MSH2, MSH6, PMS2, or EPCAM genes - You are between 20–75 years old (MLH1, MSH2, EPCAM carriers) or 30–75 years old (PMS2 or MSH6 carriers) - You have an upcoming standard colonoscopy as part of your routine Lynch syndrome surveillance - You are willing to collect stool samples and complete surveys **You may NOT be eligible if...** - You have not yet had genetic testing confirming Lynch syndrome - You have previously had a partial or total bowel removal (colectomy) - You have inflammatory bowel disease or an active cancer - You are pregnant - You are a newly diagnosed Lynch syndrome patient below the minimum age thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFecal immunochemical test

Detects blood in stool


Locations(3)

The University of Chicago Medical Center

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Columbia University

New York, New York, United States

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NCT06898996


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