Colorectal Cancer
Conditions
Keywords
Cologuard
Brief summary
The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.
Detailed description
Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.
Interventions
OTHERCologuard
Observational
Sponsors
Exact Sciences Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject falls into one of the 4 sub-populations * Willing to provide informed consent
Exclusion criteria
* Death * Investigator/sponsor decision * Subject withdrew consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with discordant results that can be attributed to intercurrent disease | 3 years after positive Cologuard result | A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview. |
Countries
United States
Outcome results
None listed