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Clinical Trial Summary

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.


Clinical Trial Description

This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02419716
Study type Observational
Source Exact Sciences Corporation
Contact
Status Completed
Phase
Start date April 2015
Completion date March 16, 2020

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