Clinical trial · Observational
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)
Observational Study of Sub-populations From "A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval"/Protocol 2014-01 Post-Approval Study
NCT03705013CI-TRIAL-00044628terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cologuard | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Baseline Cologuard positive and negative colonoscopy
- description
- Those whose Cologuard T0 result was positive and colonoscopy result was negative.
- interventionNames
- Other: Cologuard
- label
- Baseline Cologuard positive and no colonoscopy
- description
- Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol.
- interventionNames
- Other: Cologuard
- label
- 3-year follow-up Cologuard positive and negative colonoscopy
- description
- Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative.
- interventionNames
- Other: Cologuard
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Subject falls into one of the 4 sub-populations * Willing to provide informed consent Exclusion Criteria: * Death * Investigator/sponsor decision * Subject withdrew consent
References
Publications (0)
Data not yet available
No reference posted for this study.