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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: mt-sDNA 2.0 screening test
* Diagnostic Test: FIT test
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals eligible for CRC Screening<br>Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy. | Diagnostic Test: mt-sDNA 2.0 screening test<br>* Stool samples will be collected by the subject for the mt-sDNA screening test.<br>Diagnostic Test: FIT test<br>* Stool samples will be collected by the subject for the FIT test.<br>Procedure: Colonoscopy<br>* Subjects will undergo a screening colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for CRC with the mt-sDNA 2.0 test |  | Through study completion, an average of 180 days | 
| Specificity with the mt-sDNA 2.0 test |  | Through study completion, an average of 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Sensitivity for advanced precancerous lesions compared to 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sample Collection, Stool DNA, Colonoscopy