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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

NCT03728348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 983

Last updated 2021-06-04

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Exact Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas Imperiale, MD · Indiana University

Eligibility

Min Age
45 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2019-06-18
Completion
2019-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728348 on ClinicalTrials.gov