Head to Head Study Epi proColon and FIT
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01580540
- Lead Sponsor
- Epigenomics, Inc
- Brief Summary
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.
- Detailed Description
There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers.
Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need.
This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin. At completion of testing.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (70)
Clinical Research of Puerto Rico
🇵🇷San Juan, Puerto Rico
PMI Research
🇺🇸Atlanta, Georgia, United States
Palm Springs Research Institute, Inc
🇺🇸Miami, Florida, United States
Saint Francis Cancer Care Center
🇺🇸Indianapolis, Indiana, United States
Advance Medical Research Service Corp.
🇺🇸Miami, Florida, United States
Gastroenterology Research Consultants of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Achieve Clinical Research LLC
🇺🇸Birmingham, Alabama, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
Legacy Pharma Research
🇺🇸Bismarck, North Dakota, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Center for Gastrointestinal Disorders
🇺🇸Hollywood, Florida, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Atlantic Medical Group
🇺🇸Kinston, North Carolina, United States
Piedmont Medical Research Associates, LLC
🇺🇸Winston-Salem, North Carolina, United States
Life Medi-research and Management
🇺🇸Brooklyn, New York, United States
South Orange County Surgical Medical Group
🇺🇸Laguna Hills, California, United States
Santa Monica Research Institute
🇺🇸Santa Monica, California, United States
Diverse Research Solutions, LLC
🇺🇸Oxnard, California, United States
Healthcare Partners Medical Group
🇺🇸Los Angeles, California, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
United Clinical Research, Corp.
🇺🇸Miami, Florida, United States
Greater Arizona Gastroenterology Associates
🇺🇸Casa Grande, Arizona, United States
Southern California Research Institute Medical Group, Inc.
🇺🇸Murrieta, California, United States
Inland Gastroenterology Medical Associates, Inc.
🇺🇸Redlands, California, United States
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Zasa Clinical Research
🇺🇸Boyton Beach, Florida, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Binghampton Gastroenterology Associates
🇺🇸Binghampton, New York, United States
Futura Research, Inc.
🇺🇸Montebello, California, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
West Gastroenterology Medical Group
🇺🇸Murrieta, California, United States
Middlesex Hospital Cancer Center
🇺🇸Middletown, Connecticut, United States
Physicians Regional Medical Center
🇺🇸Naples, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸Rockford, Illinois, United States
Trover Center for Clinical Studies
🇺🇸Madisonville, Kentucky, United States
New York Gastroenterology Associates, LLP
🇺🇸New York, New York, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group
🇺🇸Chevy Chase, Maryland, United States
Bassett Healthcare Center
🇺🇸Cooperstown, New York, United States
Detroit Clinical Research Center
🇺🇸Novi, Michigan, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Spring Gastroenterology
🇺🇸Spring, Texas, United States
Montefiore - Einstein Cancer Care Center
🇺🇸New York, New York, United States
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Troy Gastroenterology PC Center for Digestive Health
🇺🇸Troy, Michigan, United States
Charlotte Gastroenterology and Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Carolina Digestive Health Associates
🇺🇸Charlotte, North Carolina, United States
Clinical Trials of America, Inc.
🇺🇸Eugene, Oregon, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Multicare Health Systems, Medical Oncology
🇺🇸Tacoma, Washington, United States
Bux-Mont Gastroenterology Associates
🇺🇸Sellersville, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Independent Clinical Research, LLC
🇺🇸Carrolton, Texas, United States
Digestive Associates of Houston
🇺🇸Spring, Texas, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Dean Foundation Medical Research
🇺🇸Madison, Wisconsin, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Advance Medical Research Group
🇺🇸Palm Harbor, Florida, United States
Commonwealth Clinical Trials
🇺🇸Brockton, Massachusetts, United States