Status:
RECRUITING
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Columbia University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-75 years
Brief 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 s...
Detailed Description
Lynch syndrome (LS), the most common inherited cause of colorectal cancer (CRC) affecting about 1.2 million Americans. Colonoscopy starting early in adulthood and repeated yearly or biennially is the ...
Eligibility Criteria
Inclusion
- Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
- Aged 20 - 75 years (for those with pathogenic variants in MLH1, MSH2, and EPCAM)
- Aged 30 - 75 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).
- Willing to sign informed consent, collect stools samples and complete surveys
Exclusion
- 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 have previously undergone a subtotal or total colectomy.
- 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.
- Individuals who are pregnant.
- Individuals with inflammatory bowel disease or active malignancy.
- Individuals not willing or able to sign informed consent.
Key Trial Info
Start Date :
July 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06898996
Start Date
July 10 2025
End Date
July 1 2029
Last Update
September 8 2025
Active Locations (3)
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1
The University of Chicago Medical Center
Chicago, Illinois, United States, 60639
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Columbia University
New York, New York, United States, 10032