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

Active, not recruiting

• Conditions: Colon Cancer
• Interventions: Device: Cologuard

• Registration Number: NCT04124406
• Lead Sponsor: Exact Sciences Corporation

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-10-18
• Primary Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults Prescribed Cologuard	Cologuard	Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.

Primary Outcome Measures

Name	Time	Method
Enrollment of Subjects	3 years	Enrollment of 150,000 subjects

Secondary Outcome Measures

Name	Time	Method
Diagnostic colonoscopy	4.5 years	Proportion having diagnostic colonoscopy within 1 year after positive CG test
CRC Frequency	10 years	Frequency of CRC among enrollees
National Rates Comparison	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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States