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

Completed

Conditions studied: Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

In brief

The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Key facts

Study ID

NCT01260168

Run by

Exact Sciences Corporation

People needed

435

Starts

2010-10-01

Expected to finish

2013-11-01

Last updated by the study team

2015-05-13

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
• Subject has a history of any inflammatory bowel disease.
• Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
• 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.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Clinical Research Associates — Huntsville, Alabama, United States
• Atlanta Gastroenterology — Atlanta, Georgia, United States
• Jesse Brown VA — Chicago, Illinois, United States
• Rush University Gastroenterologists — Chicago, Illinois, United States
• Stroger Cook County — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Rockford Gastroenterology Associates, Ltd — Rockford, Illinois, United States
• Gastroenterology Associates — Baton Rouge, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• Long Island Gastrointestinal Group — Great Neck, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Asheville Gastroenterology — Asheville, North Carolina, United States
• Southern Gastroenterology Associates — New Bern, North Carolina, United States
• Northwest Gastroenterology Clinic, LLC — Portland, Oregon, United States
• Gastro One — Germantown, Tennessee, United States
• Digestive Health Specialists — Tyler, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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