Evaluating the Cologuard Test for Use in Lynch Syndrome
Withdrawn before enrolling
Conditions studied: Lynch Syndrome, Colorectal Cancer, Colonic Adenoma, Colonic Polyp
In brief
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 be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.
Key facts
- Study ID
- NCT04778566
- Run by
- Geisinger Clinic
- People needed
- 0
- Starts
- 2021-11-01
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2021-11-17
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients age 18-89
- Diagnosis of genetically confirmed LS
- Scheduled for standard of care colonoscopy within 60 days of enrollment
You may not qualify if…
- 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
Where it is running
- Geisinger Health — Danville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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