Colon CancerNCT04124406
Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
An observational study of Colon Cancer, run by Exact Sciences Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Cologuard
- Type of treatment
- Medical device
- How many people
- 150,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2019to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Cologuard
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CologuardDevice
multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test
| Study group | Role | What they receive |
|---|---|---|
| Adults Prescribed Cologuard | Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider. Receives: Device: Cologuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of Subjects
Enrollment of 150,000 subjects
Measured: 3 years
Secondary outcomes (3)
Diagnostic colonoscopy
Proportion having diagnostic colonoscopy within 1 year after positive CG test
Measured: 4.5 years
CRC Frequency
Frequency of CRC among enrollees
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start18 Oct 2019
- Primary completion31 Dec 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124406
- Sponsor's protocol ID
- 2019-08
- Status last verified
- Sep 2025
- First submitted
- 10 Oct 2019
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Yost KJ, Carlson RE, Kirt CR, Kirsch EJ, Kneedler B, Laffin JJ, St Sauver JL, Finney Rutten LJ, Grimm JA, Olson JE. Recruitment strategies and consent rates in a national prospective colorectal cancer screening cohort: results from year 1 of the Voyage Study. BMJ Open Gastroenterol. 2024 Jul 17;11(1):e001376. doi: 10.1136/bmjgast-2024-001376.
PubMed 39019622Olson 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.
PubMed 32128228
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voyage: Real-World Impact of the Multi-target Stool DNA Test on CRC Screening and Mortality
- ClinicalTrials.gov ID
- NCT04124406
- Acronym / sponsor ID
- 2019-08
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Prescribed Cologuard | – | Device: CologuardAdults prescribed Cologuard for routine colon cancer screening by their healthcare provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults prescribed Cologuard for routine colon cancer screening by their healthcare provider.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cologuardmulti-target stool Deoxyribonucleic Acid (MT-sDNA) screening test | Device | Adults Prescribed Cologuard |
Primary outcome
Enrollment of Subjects
Time frame: 3 years
Enrollment of 150,000 subjects
3 secondary outcomes
Diagnostic colonoscopy
Time frame: 4.5 years
CRC Frequency
Time frame: 10 years
National Rates Comparison
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 39019622Yost KJ, Carlson RE, Kirt CR, Kirsch EJ, Kneedler B, Laffin JJ, St Sauver JL, Finney Rutten LJ, Grimm JA, Olson JE. Recruitment strategies and consent rates in a national prospective colorectal cancer screening cohort: results from year 1 of the Voyage Study. BMJ Open Gastroenterol. 2024 Jul 17;11(1):e001376. doi: 10.1136/bmjgast-2024-001376.
- Derived from this study: PubMed 32128228Olson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Exact Sciences Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of Subjects (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124406, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.