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OpenTrials
Active, Not Recruiting

NCT Number: NCT04124406

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cologuard

Device

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

Primary outcomes

  1. Enrollment of Subjects

    Time frame: 3 years

    Enrollment of 150,000 subjects

Secondary outcomes

  1. Diagnostic colonoscopy

    Time frame: 4.5 years

    Proportion having diagnostic colonoscopy within 1 year after positive CG test

  2. CRC Frequency

    Time frame: 10 years

    Frequency of CRC among enrollees

  3. National Rates Comparison

    Time frame: 10 years

    Comparison with national rates (i.e., SEER cancer registry rates) adjusted to reflect a) the age- and sex- distribution of CG users, b) that 25% of colorectal cancers occur in high risk patients, and c) the attrition rate of our longitudinal cohort

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Collaborators

  • Mayo Clinic

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Oct 11, 2019
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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