FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
The University of Chicago Medical Center
RECRUITING
Chicago
Michigan
University of Michigan
RECRUITING
Ann Arbor
New York
Columbia University
RECRUITING
New York
Contact Information
Primary
Sonia Kupfer, MD
skupfer@bsd.uchicago.edu
(773) 834-1438
Backup
Kristi Kearney, RN
kkearney@bsd.uchicago.edu
773-834-7414
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2029-07-01
Participants
Target number of participants: 400
Treatments
Non-invasive surveillance test
Easily accessible, affordable and acceptable tests can be used to triage Lynch syndrome patients to colonoscopy
Related Therapeutic Areas
Sponsors
Collaborators: Columbia University, University of Michigan, National Cancer Institute (NCI)
Leads: University of Chicago