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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124406
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colon Cancer Device: Cologuard

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.

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Study Type : Observational
Estimated Enrollment : 150000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort Intervention/treatment
Adults Prescribed Cologuard
Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
Device: Cologuard
multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test




Primary Outcome Measures :
  1. Enrollment of Subjects [ Time Frame: 3 years ]
    Enrollment of 150,000 subjects


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124406


Contacts
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Contact: Alexandra Massoud 608-957-5652 amassoud@exactsciences.com

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Janet E. Olson, Ph.D    833-242-4428    VOYAGESTUDY@mayo.edu   
Sponsors and Collaborators
Exact Sciences Corporation
Mayo Clinic
Investigators
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Study Director: Natalia Voge, MD, PhD Exact Sciences

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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT04124406     History of Changes
Other Study ID Numbers: Exact-001
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (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
Informed Consent Form (ICF)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases