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

Colorectal Cancer Clinical Trial

Official title: 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

Status Terminated

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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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