Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT02419716
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2015-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Sponsor:
Exact Sciences Corporation
Organization:
Study Overview
Official Title:
A Longitudinal Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: