Clinical trial · Observational
Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
NCT04124406CI-TRIAL-00096248active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to gather information about the long term health of people who have been prescribed the Cologuard test, which is used for colorectal cancer (CRC) screening.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cologuard | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults Prescribed Cologuard
- description
- Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
- interventionNames
- Device: Cologuard
Primary outcomes (1)
- measure
- Enrollment of Subjects
- timeFrame
- 3 years
- description
- Enrollment of 150,000 subjects
Secondary outcomes (3)
- measure
- Diagnostic colonoscopy
- timeFrame
- 4.5 years
- description
- Proportion having diagnostic colonoscopy within 1 year after positive CG test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Resident of the United States * Age 18 years or older * Able to provide informed consent * Able to complete surveys in English or Spanish * Valid order for Cologuard screening Exclusion Criteria: * N/A
References
Publications (2)
- DERIVEDYost KJ, Carlson RE, Kirt CR, Kirsch EJ, Kneedler B, Laffin JJ, St Sauver JL, Finney Rutten LJ, Grimm JA, Olson JE. Recruitment strategies and consent rates in a national prospective colorectal cancer screening cohort: results from year 1 of the Voyage Study. BMJ Open Gastroenterol. 2024 Jul 17;11(1):e001376. doi: 10.1136/bmjgast-2024-001376. PMID 39019622
- DERIVEDOlson JE, Kirsch EJ, Edwards V DK, Kirt CR, Kneedler B, Laffin JJ, Weaver AL, St Sauver JL, Yost KJ, Finney Rutten LJ. Colorectal cancer outcomes after screening with the multi-target stool DNA assay: protocol for a large-scale, prospective cohort study (the Voyage study). BMJ Open Gastroenterol. 2020 Feb 19;7(1):e000353. doi: 10.1136/bmjgast-2019-000353. eCollection 2020. PMID 32128228