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

ID#: NCT04144738

Age: 40 years - 66+

Gender: All

Healthy Subjects: Accepts Healthy Volunteers

Recruitment Status: Recruiting

Start Date: November 15, 2019

End Date: April 30, 2022

Contact Information:
Cristina Villagra
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.

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.