Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers

Stopped early

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

In brief

The primary objective of this study is to obtain de-identified, clinically characterized, stool and plasma specimens for use in assessing new markers for the detection of neoplasms of the digestive tract.

Key facts

Study ID

NCT02503631

Run by

Exact Sciences Corporation

People needed

397

Starts

2014-10-01

Expected to finish

2017-09-01

Last updated by the study team

2018-04-06

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 or colorectal polyp/adenoma/mass that is equal or larger than 1 cm in pre-enrollment colonoscopy with residual lesion in the colon of sufficient size to require additional surgical excision or complex colonoscopic polypectomy.
• Subject understands the study procedures and is able to provided 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 actively bleeding hemorrhoids (blood on toilet paper or bright red blood clots in the toilet bowel during bowel movement).
• 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

• John D. Homan, MD — Newport Beach, California, United States
• Medical Research Center of Connecticut — Hamden, Connecticut, United States
• Gulf Coast Research Group, LLC — Holiday, Florida, United States
• Endoscopic Research, Inc. — Orlando, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Colon and Rectal Surgery Associates — Metairie, Louisiana, United States
• New Orleans Research Institute — Metairie, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• DBA Boone Hospital Center — Columbia, Missouri, United States
• Sundance Clinical Research, LLC — St Louis, Missouri, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
• Cumberland Research Associates, LLC — Fayetteville, North Carolina, United States
• Northwest Gastroenterology Clinic, LLC — Portland, Oregon, United States
• Main Line Gastroenterology Associates — Malvern, Pennsylvania, United States
• Radiant Research, Inc. — Anderson, South Carolina, United States
• Gastro One — Germantown, Tennessee, United States
• Blue Ridge Medical Researcj — Lynchburg, Virginia, United States
• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States
• Forzani & MacPhali Colon Cancer Screening Centre — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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