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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT04144738
• Lead Sponsor: Exact Sciences Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-15
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26758

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.

8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity with the mt-sDNA 2.0 test	Through study completion, an average of 180 days
Sensitivity for CRC with the mt-sDNA 2.0 test	Through study completion, an average of 180 days

Secondary Outcome Measures

Name	Time	Method
Sensitivity for advanced precancerous lesions compared to commercially available fecal immunochemical test (FIT).	Through study completion, an average of 180 days
Sensitivity for advanced precancerous lesions	Through study completion, an average of 180 days
Sensitivity for CRC compared to a commercially available fecal immunochemical test (FIT)	Through study completion, an average of 180 days
Specificity for no colorectal neoplastic findings	Through study completion, an average of 180 days

Trial Locations

Locations (187)

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

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