Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)

Study Overview
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Brief Summary
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The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.

Detailed Description
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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.

Official Title
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Observational Study of Sub-populations From A Longitudinal Study of Cologuard in an Average Risk Population Assessing a Three Year Test Interval/Protocol 2014-01 Post-Approval Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Cologuard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline Cologuard positive and negative colonoscopy<br>Those whose Cologuard T0 result was positive and colonoscopy result was negative. | Other: Cologuard<br>* Observational<br>|
| Baseline Cologuard positive and no colonoscopy<br>Those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. | Other: Cologuard<br>* Observational<br>|
| 3-year follow-up Cologuard positive and negative colonoscopy<br>Those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. | Other: Cologuard<br>* Observational<br>|
| 3-year follow-up Cologuard positive and no colonoscopy<br>Those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. | Other: Cologuard<br>* Observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with discordant results that can be attributed to intercurrent disease | A medical chart review and phone interview will be conducted for each subject. The Follow-Up Questionnaire will be completed during the phone interview. | 3 years after positive Cologuard result | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cologuard