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

Completed

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

In brief

The objective of this study is to confirm the sensitivity and specificity of a stool DNA test for detection of colorectal cancer and pre-cancer.

Key facts

Study ID

NCT01600209

Run by

Exact Sciences Corporation

People needed

674

Starts

2011-10-01

Expected to finish

2012-09-01

Last updated by the study team

2015-05-13

Who can join

Age: 50 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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) months.
• 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 bleeding)
• 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 offspring).
• One first-degree relative with CRC diagnosed before the age of 60.
• Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP).
• 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.

Where it is running

• Desert Sun Clinical Research — Tucson, Arizona, United States
• Remek Research — Pomona, California, United States
• Sharp Rees-Stealy — San Diego, California, United States
• Southern California Medical Gastroenterology Group, Inc — Santa Monica, California, United States
• Miami Research Associates — Miami, Florida, United States
• Atlanta Gastroenterology Associates — Marietta, Georgia, United States
• Rockford Gastroenterology Associates, LTD. — Rockford, Illinois, United States
• New Orleans Research Institue — Metairie, Louisiana, United States
• Columbia Medical Practice — Columbia, Maryland, United States
• Main Line Gastroenterology — Perkasie, Pennsylvania, United States
• Professional Quality Research, Inc. — Austin, Texas, United States
• Advanced Research Institute — Ogden, Utah, United States
• Advanced Research Institute — Sandy City, Utah, United States

Full record on ClinicalTrials.gov

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