NCT04144738CompletedNot Applicable
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 enrollmentStarted: November 15, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Exact Sciences Corporation
- Enrollment
- 26,758
- Locations
- 187
- Primary Endpoint
- Specificity with the mt-sDNA 2.0 test
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
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)
Investigators
Study Sites (187)
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