Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Trial Information

Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be
asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the
option of submitting blood and tissue samples for future colo-rectal cancer-related test
development.

Inclusion Criteria:

1. Subject is male or female, 40-90 years of age, inclusive.

2. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or
≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient
size to require surgical excision or complex colonoscopic polypectomy.

3. 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:

1. Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung,
esophagus, stomach, or pancreatic cancer).

2. Subject has a history of any inflammatory bowel disease.

3. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal
cancer (Lynch) syndrome, or other hereditary cancer syndromes.

4. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only

Outcome Measure:

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

Outcome Description:

The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.

Outcome Time Frame:

12 Months

Safety Issue:

Principal Investigator

Graham Lidgard, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chief Scientific Officer

Authority:

United States: Institutional Review Board

Study ID:

Exact Sciences 2010-A

NCT ID:

NCT01260168

Start Date:

October 2010

Completion Date:

August 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

Name	Location
Mount Sinai School of Medicine	New York, New York 10029
University of Illinois at Chicago	Chicago, Illinois 60612
University of Utah	Salt Lake City, Utah
Chevy Chase Clinical Research	Chevy Chase, Maryland
Achieve Clinical Research, LLC	Tuscaloosa, Alabama 35406
Gastroenterology Associates	Baton Rouge, Louisiana 70809
Southern Gastroenterology Associates	New Bern, North Carolina 28562
Clinical Research Associates	Huntsville, Alabama 35801
Atlanta Gastroenterology	Atlanta, Georgia 30308
Stroger Cook County	Chicago, Illinois 60612
Rush University Gastroenterologists	Chicago, Illinois 60612
Jesse Brown VA	Chicago, Illinois 60612
Rockford Gastroenterology Associates, Ltd	Rockford, Illinois 61107
Commonwealth Clinical Studies	Brockton, Massachusetts 02302
Long Island Gastrointestinal Group	Great Neck, New York 11023
Asheville Gastroenterology	Asheville, North Carolina 28801
Northwest Gastroenterology Clinic, LLC	Portland, Oregon 97208
Gastro One	Germantown, Tennessee 38138
Digestive Health Specialists	Tyler, Texas 75701
Digestive and Liver Disease Specialists	Norfolk, Virginia 23502

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