RECRUITING

FITting Non-invasive Tests in Lynch Syndrome Surveillance

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Conditions

Colorectal CancerLynch Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

FITting Non-invasive Testing Into Lynch Syndrome Colorectal Cancer Surveillance: a Multi-center, Prospective Study

Quick Facts

Study Start:2025-09-01
Study Completion:2035-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06898996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
  2. * Aged 20 - 75 years
  3. * Have an upcoming standard of care (SOC) colonoscopy appointment in line with standard LS surveillance guidelines (NCCN).
  4. * Willing to sign informed consent, collect stools samples and complete surveys
  1. * Individuals who have not proceeded with genetic testing and therefore are not known to have LS, despite family history and/or criteria for testing.
  2. * Individuals who have previously undergone a subtotal or total colectomy.
  3. * Newly diagnosed Lynch Syndrome patients \< 20 years old with a pathogenic variant in MLH1, MSH2 or EPCAM, MSH6 or PMS2.
  4. * Individuals who are pregnant.
  5. * Individuals with inflammatory bowel disease or active malignancy.
  6. * Individuals not willing or able to sign informed consent.

Contacts and Locations

Study Contact

Sonia Kupfer, MD
CONTACT
(773) 834-1438
skupfer@bsd.uchicago.edu
Kristi Kearney, RN
CONTACT
773-834-7414
kkearney@bsd.uchicago.edu

Principal Investigator

Sonia Kupfer, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University of Chicago Medical Center
Chicago, Illinois, 60639
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Columbia University
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Sonia Kupfer, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2035-04-01

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2035-04-01

Terms related to this study

Keywords Provided by Researchers

  • Lynch Syndrome
  • Colorectal Cancer

Additional Relevant MeSH Terms

  • Colorectal Cancer