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

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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•Exact Sciences Corporation

View on ClinicalTrials.gov

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.

Detailed Description

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects must meet the following criteria to be eligible for the study:
•1. Subject is ≥ 40 years of age at the time of enrollment.
•2. Subject presents for a screening colonoscopy per standard of care.
•3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
•4. Subject is able and willing to sign informed consent

Exclusion Criteria

•1. Subject has a history of CRC or advanced precancerous lesions.
•2. Subject has a diagnosis or medical / family history of any of the following conditions, including:
•* Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
•* Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
•* Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
•3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
•4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
•5. Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
•6. Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
•7. Subject has had overt rectal bleeding within the previous 30 days.
+1 more criteria

Locations (195)

Parkway Medical Center

Birmingham, Alabama, United States

Summit Internal Medicine, PC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

G & L Research

Foley, Alabama, United States

Medical Affiliated Research Center

Huntsville, Alabama, United States

East View Medical Research, LLC

Mobile, Alabama, United States

GI Associates of West Alabama, P.C

Tuscaloosa, Alabama, United States

Mayo Clinic - AZ

Phoenix, Arizona, United States

Key Dates

Start Date

November 15, 2019

Primary Completion Date

March 30, 2023

Completion Date

March 30, 2023

Last Updated

September 1, 2023

Enrollment

26,758

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

mt-sDNA 2.0 screening test

DIAGNOSTIC_TEST

FIT test

DIAGNOSTIC_TEST

Colonoscopy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors