Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Inclusion Criteria:

• Subject is male or female, 40 years of age or older.
• Subject is at average or increased risk for development of CRC.
• Subject presents for screening or surveillance colonoscopy.
• Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
• Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

• Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.

• Subject has a diagnosis or personal history of any of the following conditions, including:

  1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  3. 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 and Familial Hyperplastic Polyposis.

• Subject has a family history of:

  1. Familial adenomatous polyposis (also referred to as "FAP").
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").

• Subjects with Cronkhite-Canada Syndrome.

• IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

• Subject has any condition that in the opinion of the Investigator should preclude participation in the study