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

Exact Sciences Corporation

Status: Completed

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT03821948

2018-08

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 5,131 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

5,131 participants in 2 patient groups

Average CRC Risk Group

Description:

Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure

Increased CRC Risk Group

Description:

Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure