Clinical trial · Observational
Evaluating the Cologuard Test for Use in Lynch Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recent discovery of a novel assay that is more likely to be beneficial for patients with Lynch Syndrome. Investing into current version of Cologuard test would provide little clinical benefit.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Adenoma | Colon Adenoma | ALIAS | 0.90 |
| Colonic Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cologuard test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cologuard Study Group
- description
- Within 60 days of their already scheduled screening colonoscopy, participants will provide a stool sample to be tested by a Cologuard screening test kit. Participants will also complete surveys prior to their colonoscopy as well as post colonoscopy.
- interventionNames
- Diagnostic Test: Cologuard test
Primary outcomes (1)
- measure
- Evaluate the feasibility of the Cologuard test for Lynch Syndrome
- timeFrame
- 3 months
- description
- To evaluate the feasibility of Cologuard in a high-risk population, a summary report of the enrollment/consent rate and adherence to the protocol will be provided. Additional analyses comparing the results (given as positive/negative) Cologuard with the gold standard of colonoscopy will be performed using diagnostic tests including sensitivity, specificity, positive predictive value and negative predictive value.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age 18-89 * Diagnosis of genetically confirmed LS * Scheduled for standard of care colonoscopy within 60 days of enrollment Exclusion Criteria: * 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
References
Publications (0)
Data not yet available