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

Exact Sciences Corporation187 sites in 1 country26,758 target enrollmentNovember 15, 2019

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Exact Sciences Corporation
Enrollment: 26758
Locations: 187
Primary Endpoint: Specificity with the mt-sDNA 2.0 test
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2019

End Date

March 30, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Exact Sciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Subject has a history of CRC or advanced precancerous lesions.
•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.
•Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
•Subject has a diagnosis of Cronkhite-Canada Syndrome.
•Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
•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.
•Subject has had overt rectal bleeding within the previous 30 days.

Outcomes

Primary Outcomes

Specificity with the mt-sDNA 2.0 test

Time Frame: Through study completion, an average of 180 days

Sensitivity for CRC with the mt-sDNA 2.0 test

Time Frame: Through study completion, an average of 180 days

Secondary Outcomes

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)