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

• ClinicalTrials.gov Identifier: NCT04124406
• Recruitment Status: Active, not recruiting
• First Posted: October 11, 2019
• Last Update Posted: February 20, 2024
• Sponsor: Exact Sciences Corporation
• Collaborator: Mayo Clinic
• Information provided by (Responsible Party): Exact Sciences Corporation

Tracking Information

• First Submitted Date: October 10, 2019
• First Posted Date: October 11, 2019
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: October 18, 2019
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2019)

Enrollment of Subjects [ Time Frame: 3 years ]

Enrollment of 150,000 subjects

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 10, 2019)

• Diagnostic colonoscopy [ Time Frame: 4.5 years ]
  Proportion having diagnostic colonoscopy within 1 year after positive CG test
• CRC Frequency [ Time Frame: 10 years ]
  Frequency of CRC among enrollees
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
• Official Title: Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
• Condition: Colon Cancer

Intervention

Device: Cologuard

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

Study Groups/Cohorts

Adults Prescribed Cologuard

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

Intervention: Device: Cologuard

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 10, 2019): 150000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2029
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04124406
• Other Study ID Numbers: 2019-08
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (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.

• Current Responsible Party: Exact Sciences Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Exact Sciences Corporation
• Original Study Sponsor: Same as current
• Collaborators: Mayo Clinic
• Investigators: Not Provided
• PRS Account: Exact Sciences Corporation
• Verification Date: February 2024