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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03705013
Study type Observational
Source Exact Sciences Corporation
Contact
Status Terminated
Phase
Start date October 30, 2018
Completion date November 16, 2019

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