Status:
WITHDRAWN
Evaluating the Cologuard Test for Use in Lynch Syndrome
Lead Sponsor:
Geisinger Clinic
Conditions:
Lynch Syndrome
Colorectal Cancer
Eligibility:
All Genders
18-89 years
Brief Summary
This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will...
Detailed Description
The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscop...
Eligibility Criteria
Inclusion
- Patients age 18-89
- Diagnosis of genetically confirmed LS
- Scheduled for standard of care colonoscopy within 60 days of enrollment
Exclusion
- Diagnosis of other inherited genetic disorders that increase risk for Colorectal Cancer (CRC) (Familial Adenomatous Polyposis (FAP), Cowden's syndrome, Turcot syndrome, Gardner syndrome, and Peutz-Jeghers syndrome)
- Diagnosis of other inherited Inflammatory bowel disease (i.e. Crohn disease, ulcerative colitis)
- Others with elevated risk of CRC outside of the inclusion criteria (i.e. ≥2 first-degree relatives who have been diagnosed with CRC without a defined inherited genetic disorder, Hereditary Non-Polyposis Colon Cancer (HNPCC) without genetic confirmation of LS)
- Participation in any interventional clinical study within the previous 30 days
- Personal history of CRC not in full remission (5 consecutive cancer-free years)
- Current active treatment with chemotherapy
- Treatment with chemotherapy within 12 months prior to consent date
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04778566
Start Date
November 1 2021
End Date
September 1 2022
Last Update
November 17 2021
Active Locations (1)
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1
Geisinger Health
Danville, Pennsylvania, United States, 17822