Shield Post-Approval Study Protocol

Summary

The Shield post-approval study (PAS) is a prospective, longitudinal study supplemented with Real World Evidence (RWE) to evaluate the longitudinal performance of Shield in an average risk population at a second round of testing for individuals between the ages of 45 and 81 at average risk of CRC using colonoscopy as the reference method.

Eligibility

Inclusion Criteria:

1. Subjects aged 45-81 years at time of consent
2. Intending to undergo a standard of care Shield test
3. Considered by a physician or healthcare provider as being of 'average risk' for CRC; 'Average-risk' individuals in the context of CRC screening are defined as those who do not have symptoms of CRC and do not have increased risk factors for the disease (i.e., prior diagnosis of CRC, adenomatous polyps, or inflammatory bowel disease; family history of CRC or known hereditary predisposition to CRC).
4. Subject agrees to comply with study procedures and associated standard of care assessments.

Exclusion Criteria:

1. Undergoing colonoscopy for investigation of symptoms
2. Personal history of colorectal cancer (CRC), adenomas, or other related cancers
3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age
4. Positive result on another colorectal cancer screening method within the last six months, or:

   * 12 months for fecal occult blood test (FOBT) or fecal immunochemical test (FIT)
   * 36 months for FIT-DNA test
5. Personal history of any of the following high-risk conditions for colorectal cancer:

   * Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease
   * Familial adenomatous polyposis (FAP)
   * Other hereditary cancer syndromes including but not limited to:

     * Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz- Jeghers Syndrome, MUTYH Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
6. Positive Shield test result within the previous 3 years
7. History of any malignancy (patients who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study)
8. Known diagnosis of inflammatory bowel disease
9. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs (DMARDs)
10. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent
11. Known medical condition which, in the opinion of the Investigator, should preclude enrollment into the study
12. Participation in a clinical research study in which an experimental medication has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of colonoscopy

Conditions2

Locations43 sites

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