Head to Head Study Epi proColon and FIT

Completed

Conditions studied: Colorectal Cancer

In brief

The study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects.

Key facts

Study ID

NCT01580540

Run by

Epigenomics, Inc

People needed

336

Starts

2012-03-01

Expected to finish

2012-11-01

Last updated by the study team

2015-08-04

Who can join

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

You may qualify if…

• Group A
• Willing and able to sign an informed consent and adhere to study requirements
• 50 - 84 years of age at blood and stool sampling
• Colonoscopic diagnosis of colorectal carcinoma
• Colonoscopy within 6 months before inclusion into study
• Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
• Group B
• Willing and able to sign an informed consent and adhere to study requirements
• 50 - 84 years of age at blood and stool sampling
• Able to provide blood and stool sample prior to bowel prep and colonoscopy

You may not qualify if…

• Group A
• Subject with curative biopsy during colonoscopy
• Group A and B
• Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
• Neoadjuvant treatment
• Familial risk for colorectal cancer
• History of inflammatory bowel disease
• Acute or chronic gastritis
• Current diagnosis of any other cancer
• Overt rectal bleeding or bleeding hemorrhoids
• Known infection with HIV, HBV, or HCV
• Subject concurrently receiving intravenous fluid at the time of the sample collection

Where it is running

• Greater Arizona Gastroenterology Associates — Casa Grande, Arizona, United States
• Visions Clinical Research — Tucson, Arizona, United States
• South Orange County Surgical Medical Group — Laguna Hills, California, United States
• Healthcare Partners Medical Group — Los Angeles, California, United States
• Futura Research, Inc. — Montebello, California, United States
• Southern California Research Institute Medical Group, Inc. — Murrieta, California, United States
• West Gastroenterology Medical Group — Murrieta, California, United States
• Diverse Research Solutions, LLC — Oxnard, California, United States
• Inland Gastroenterology Medical Associates, Inc. — Redlands, California, United States
• Santa Monica Research Institute — Santa Monica, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Middlesex Hospital Cancer Center — Middletown, Connecticut, United States
• Zasa Clinical Research — Boyton Beach, Florida, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Center for Gastrointestinal Disorders — Hollywood, Florida, United States
• Palm Springs Research Institute, Inc — Miami, Florida, United States
• United Clinical Research, Corp. — Miami, Florida, United States
• Advance Medical Research Service Corp. — Miami, Florida, United States
• Physicians Regional Medical Center — Naples, Florida, United States
• Advance Medical Research Group — Palm Harbor, Florida, United States
• Accord Clinical Research, LLC — Port Orange, Florida, United States
• Stedman Clinical Trials, LLC — Tampa, Florida, United States
• PMI Research — Atlanta, Georgia, United States
• Achieve Clinical Research LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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