Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
1 other identifier
observational
150,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 3, 2025
September 1, 2025
4.2 years
October 10, 2019
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Enrollment of Subjects
Enrollment of 150,000 subjects
3 years
Secondary Outcomes (3)
Diagnostic colonoscopy
4.5 years
CRC Frequency
10 years
National Rates Comparison
10 years
Study Arms (1)
Adults Prescribed Cologuard
Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
Interventions
multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test
Eligibility Criteria
Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
You may qualify if:
- 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
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exact Sciences Corporationlead
- Mayo Cliniccollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (2)
Yost 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: 39019622DERIVEDOlson 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: 32128228DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 11, 2019
Study Start
October 18, 2019
Primary Completion
December 31, 2023
Study Completion
December 1, 2025
Last Updated
October 3, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Data will be available from 2 years and ending 4 years after publication.
- Access Criteria
- Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.
Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol (including statistical methods), informed consent form, and clinical study report will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.