FITting Non-invasive Tests in Lynch Syndrome Surveillance

Recruiting now

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT06898996

Run by

University of Chicago

People needed

400

Starts

2025-07-10

Expected to finish

2029-07-01

Last updated by the study team

2026-04-16

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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