Actively Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Led by University of Chicago · Updated on 2026-04-16
400
Participants Needed
3
Research Sites
207 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of Lynch Syndrome with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2, or EPCAM genes.
- Aged 20 to 80 years for those with variants in MLH1, MSH2, and EPCAM.
- Aged 30 to 80 years for those with variants in PMS2 or MSH6.
- Have an upcoming standard of care colonoscopy appointment following Lynch Syndrome surveillance guidelines.
- Patients with previous colon surgery who still have 20cm or more of colon remaining.
- Patients diagnosed with advanced neoplasia who have not had endoscopic or surgical resection.
- Willing to sign informed consent, provide stool samples, and complete surveys.
You will not qualify if you...
- Individuals without confirmed genetic testing for Lynch Syndrome despite family history or criteria.
- Individuals who have had subtotal or total colectomy.
- Newly diagnosed Lynch Syndrome patients under 20 years old with variants in MLH1, MSH2, EPCAM, MSH6, or PMS2.
- Newly diagnosed Lynch Syndrome patients under 30 years old with variants in MSH6 or PMS2.
- Individuals who are pregnant.
- Individuals with inflammatory bowel disease or active cancer.
- Individuals unwilling or unable to sign informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The University of Chicago Medical Center
Chicago, Illinois, United States, 60639
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Columbia University
New York, New York, United States, 10032
Actively Recruiting
Research Team
S
Sonia Kupfer, MD
CONTACT
K
Kristi Kearney, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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