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Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

NCT04144738 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26758

Last updated 2023-09-01

No results posted yet for this study

Summary

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Conditions

Interventions

DIAGNOSTIC_TEST

mt-sDNA 2.0 screening test

Stool samples will be collected by the subject for the mt-sDNA screening test.

DIAGNOSTIC_TEST

FIT test

Stool samples will be collected by the subject for the FIT 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
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2023-03-30
Completion
2023-03-30

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 NCT04144738 on ClinicalTrials.gov