Colon Cancer
Conditions
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.
Interventions
DEVICECologuard
multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test
Sponsors
Mayo Clinic
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment of Subjects | 3 years | Enrollment of 150,000 subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed