Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing

Exact Sciences Corporation

Status: Completed

Conditions: Digestive System Diseases; Colonic Diseases; Colorectal Neoplasms; Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01600209

Exact Sciences 2011-N

Details and patient eligibility

About

The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Full description

Patients who have recently undergone a colonoscopy that resulted with normal findings will be asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).

Enrollment: 674 patients

Sex: All

Ages: 50 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is male or female, 50-84 years of age, inclusive.
• Subject is at average risk for development of CRC and has undergone a screening colonoscopy with a normal result at least 30 days and no more than 120 days before providing a stool sample for the study. For the purposes of this study, a "normal" colonoscopy result is defined as no polyps of any size detected or removed (including benign, hyperplastic polyps).
• Subject is able to understand the study procedures, and is able to provide signed consent to participate in the study and authorizes release of relevant protected health information through signing a HIPAA consent.
• Subject is able and willing to provide stool samples at least 30 days and no more than 120 days after undergoing a colonoscopy that resulted in normal findings, according to the written instructions provided to them.

Exclusion criteria

• Subject has any condition which, in the opinion of the investigator should preclude participation in the study.

• Subject had any findings on recent or any previous colonoscopy including benign, and/or hyperplastic polyps of any size. (Note: Tissue biopsies that result in no histopathology findings are acceptable.)

• Subject has a history or recent diagnosis of CRC or adenoma.

• Subject has a history of aerodigestive tract cancer.

• Subject has had a positive fecal occult blood test or FIT within the previous six (6) months.

• Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease.

• Subject has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)

• Subject has a diagnosis or 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.
  • Greater than or equal to (>=)2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring).
  • One first-degree relative with CRC diagnosed before the age of 60.
  • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
  • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome").
  • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.

Trial design

674 participants in 1 patient group

Average risk patients

Description:

Subjects will be men and women, 50-84 years of age, inclusive, each with a screening colonoscopy resulting in normal findings.