Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C)

Exact Sciences Corporation

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01397747

Exact Sciences 2011-01

Details and patient eligibility

About

The primary objective is to determine the sensitivity and specificity of the Exact Colorectal Cancer (CRC) screening test for colorectal cancer, using colonoscopy as the reference method. Lesions will be confirmed as malignant by histopathologic examination.

The secondary objective is to compare the performance of the Exact CRC screening test to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Full description

Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay. Subjects will undergo colonoscopy within 90 days of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and representative histopathology slides resulting from subsequent definitive surgery may be retrieved in order to be evaluated by central pathology to confirm diagnosis and staging.

Enrollment: 12,776 patients

Sex: All

Ages: 50 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is average risk for development of colorectal cancer (as defined by the inclusion and exclusion criteria below).
2. Subject is able and willing to undergo a screening colonoscopy within 90 days of enrollment.
3. Subject is 50 to 84 years of age inclusive.
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
5. Subject is able and willing to provide stool samples according to written instructions provided to them.

Exclusion criteria

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

2. Subject has undergone colonoscopy within the previous nine (9) years.

3. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.

4. Subject has a history of colorectal cancer or adenoma.

5. Subject has a history of aerodigestive tract cancer.

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

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

8. 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).

9. 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.
   • >= 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.

10. Subject has a family history of:

    • Familial adenomatous polyposis (also referred to as "FAP").
    • Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" or "Lynch Syndrome").

11. Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups.

Trial design

12,776 participants in 1 patient group

Average risk patients

Description:

Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer.