NCT02419716

A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,404 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Cancer Screening
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Cologuard	Prescription of Cologuard for at-home stool collection

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2015-04-17
• Last updated: 2020-04-02

Locations

40 sites across 1 country: United States