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

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

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Trial Information

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

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).

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)

- 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

- 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

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only

Outcome Measure:

Sensitivity and Specificity of the Exact CRC diagnostic screening test.

Outcome Description:

The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.

Outcome Time Frame:

10 months

Safety Issue:


Principal Investigator

Graham Lidgard, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chief Scientific Officer


United States: Institutional Review Board

Study ID:

Exact Sciences 2011-N



Start Date:

October 2011

Completion Date:

September 2012

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



Atlanta Gastroenterology Associates Atlanta, Georgia  
Sharp Rees-Stealy La Mesa, California  91942
Miami Research Associates Miami, Florida  33173
Columbia Medical Practice Columbia, Maryland  21045
Rockford Gastroenterology Associates, Ltd. Rockford, Illinois  61107
REMEK Research Pomona, California  91767
Main Line Gastroenterology Bala Cynwyd, Pennsylvania  19004
Professional Quality Research, Inc. Austin, Texas  78705
Advanced Research Institute Logan, Utah  84341
Desert Sun Clinical Research Tucson, Arizona  85710
Southern California Medical Gastroenterology Group, Inc Santa Monica, California  90404
New Orleans Research Institue Metairie, Louisiana  70006