NCT03705013

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

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
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Cologuard	Observational

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-11-16
• Completion: 2019-11-16
• First posted: 2018-10-15
• Last updated: 2020-04-14

Locations

20 sites across 1 country: United States