NCT03728348

An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 983 (actual)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 45 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.

Detailed description

Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	mt-sDNA screening test	Stool samples will be collected by the subject for the mt-sDNA screening test.
PROCEDURE	Colonoscopy	Subjects will undergo a screening colonoscopy.

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-06-18
• Completion: 2019-06-18
• First posted: 2018-11-02
• Last updated: 2021-06-04
• Results posted: 2021-06-04

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated device study