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FITting non-invasive tests in Lynch syndrome surveillance: a prospective clinical trial

Primary Investigator
Stoffel, Elena
Status
OPEN TO ACCRUAL
Phase
Other
NCT Number
NCT06898996
UM Number
2024.119
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Cancer Control and Prevention
ID (Protocol)
59063
Secondary Protocol No
HUM00262506
Scope
Unspecified
Sponsor Type
Externally Peer-Reviewed
Disease Site
Colon
Rectum
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: Inclusion 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
Exclusion Criteria
  •   * 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.