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NCT04124406 Clinical Trial

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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04124406
Other study ID # 2019-08
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 18, 2019
Est. completion date December 2029

Study information
Verified date June 2024
Source Exact Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150000
Est. completion date December 2029
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Cologuard
multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Exact Sciences Corporation Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enrollment of Subjects Enrollment of 150,000 subjects 3 years
Secondary Diagnostic colonoscopy Proportion having diagnostic colonoscopy within 1 year after positive CG test 4.5 years
Secondary CRC Frequency Frequency of CRC among enrollees 10 years
Secondary National Rates Comparison 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 10 years
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