Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality

NCT ID: NCT04124406

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Participates will be consented for prospective follow-up for health outcomes, which will be ascertained through periodic contacts. Participants will complete a baseline health questionnaire survey (T0) and a 1-year follow-up questionnaire survey (T1), allow access to medical records, when available, and allow future contacts for additional surveys.

Conditions

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Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults Prescribed Cologuard

Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.

Cologuard

Intervention Type DEVICE

multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test

Interventions

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Cologuard

multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Exact Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39019622 (View on PubMed)

Olson 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.

Reference Type DERIVED
PMID: 32128228 (View on PubMed)

Other Identifiers

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2019-08

Identifier Type: -

Identifier Source: org_study_id

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