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

50 Years
84 Years
Not Enrolling
Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

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Trial Information

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

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.

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

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)

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

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

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Sensitivity and Specificity of the Exact CRC screening test with comparison to colonoscopy, both with respect to cancer.

Outcome Description:

An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination.

Outcome Time Frame:

14 Months

Safety Issue:


Principal Investigator

Thomas Imperiale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Principal Study Investigator


United States: Food and Drug Administration

Study ID:

Exact Sciences 2011-01



Start Date:

June 2011

Completion Date:

May 2013

Related Keywords:

  • Colorectal Neoplasms
  • Digestive System Diseases
  • Colonic Diseases
  • Colorectal Cancer
  • Cancer
  • Colorectal Cancer
  • Neoplasm
  • Colorectal Neoplasm
  • Intestinal Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Colonic Diseases
  • Intestinal Diseases
  • Rectal Diseases
  • Neoplasms
  • Colonic Diseases
  • Colorectal Neoplasms
  • Digestive System Diseases
  • Gastrointestinal Diseases
  • Adenomatous Polyps



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