FITting Non-invasive Tests in Lynch Syndrome Surveillance

This study is looking at how well a simple stool test, called a fecal immunochemical test (FIT), works compared to a colonoscopy for people with Lynch Syndrome (LS). Lynch Syndrome is an inherited condition that increases your risk of colorectal cancer. The FIT test looks for blood in your stool, which can be a sign of cancer. Researchers want to see if the FIT test can accurately find problems in people with Lynch Syndrome who are already getting regular colonoscopies. You might be able to join if you are between 20 and 80 years old, have a confirmed diagnosis of Lynch Syndrome, and have a colonoscopy appointment coming up. The main goal is to see how specific the FIT test is at finding problems over a 12-month period. The study is currently unclear about its status.

Study design: This is an observational study planning to include 400 participants. It will compare the results of a FIT test to a standard colonoscopy.
What's involved: You would undergo a fecal immunochemical test (FIT) in addition to your regularly scheduled colonoscopy.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, specificity, is measured at baseline to 12 months.

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FITting Non-invasive Tests in Lynch Syndrome Surveillance

Recruiting

Not specifiedAges 20–80Observational

University of Chicago

~400 participants

Updated 2026-04-16 on ClinicalTrials.gov

What's tested:Fecal immunochemical test

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Quantitative Measure of specificity

Measured over baseline -12 months

Conditions

Colorectal Cancer

Where it's being run

3 sites across 3 states

Illinois1

Michigan1

New York1

Study leadership

Sonia Kupfer, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Sonia Kupfer, MD

[email protected]

(773) 834-1438

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Quantitative Measure of specificitybaseline -12 months
Measure specificity of Fecal immunochemical test (FIT) in Lynch Syndrome (LS) patients undergoing colonoscopy surveillance

Trialytics