RECRUITING

FITting Non-invasive Tests in Lynch Syndrome Surveillance

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.

Conditions

Colorectal Cancer
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Related Conditions:

Colorectal Cancer

Study Overview

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Study Details

Study overview

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.

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

FITting Non-invasive Tests in Lynch Syndrome Surveillance

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Chicago

The University of Chicago Medical Center, Chicago, Illinois, United States, 60639

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

New York

Columbia University, New York, New York, United States, 10032

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have a diagnosis of LS with a confirmed pathogenic variant in MLH1, MSH2, MSH6, PMS2 or EPCAM genes.
  • * Aged 20 - 75 years
  • * 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
  • * 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.
  • * Individuals who are pregnant.
  • * Individuals with inflammatory bowel disease or active malignancy.
  • * Individuals not willing or able to sign informed consent.

Ages Eligible for Study

20 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Chicago,

Sonia Kupfer, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2035-04-01