Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population
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.
Observational
Observational Model: Case Control
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.
No
Juergen Beck, MD
Principal Investigator
Epigenomics, Inc
United States: Institutional Review Board
Epigenomics-SPR 0022
NCT01580540
March 2012
November 2012
Name | Location |
---|---|
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Middlesex Hospital Cancer Center | Middletown, Connecticut 06457 |
Research Medical Center | Kansas City, Missouri 64132 |
Gastroenterology Associates of Fairfield County | Bridgeport, Connecticut 06606 |
Asheville Gastroenterology Associates | Asheville, North Carolina 28801 |
Bend Memorial Clinic | Bend, Oregon 97701 |
Salt Lake Research | Salt Lake City, Utah 84124 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Healthcare Partners Medical Group | Torrance, California 90503 |
The Christ Hospital | Cincinnati, Ohio 45219 |
Springfield Clinic | Springfield, Illinois 62703 |
Clinical Research Associates of Tidewater | Norfolk, Virginia 23507 |
Trover Center for Clinical Studies | Madisonville, Kentucky 42431 |
Gastroenterology Associates | Kingsport, Tennessee 37660 |
Gastroenterology Associates of Tidewater | Chesapeake, Virginia 23320 |
Visions Clinical Research | Tucson, Arizona 85712 |
Legacy Pharma Research | Bismarck, North Dakota 58501 |
Carolina Digestive Health Associates | Harrisburg, North Carolina 28075 |
Beaumont Hospital | Royal Oak, Michigan 48073 |
Rockford Gastroenterology Associates, Ltd. | Rockford, Illinois 61107 |
Digestive Health Specialists, PA | Winston Salem, North Carolina 27103 |
South Orange County Surgical Medical Group | Laguna Hills, California 92653 |
Detroit Clinical Research Center | Farmington Hills, Michigan 48336 |
Digestive and Liver Disease Specialists | Norfolk, Virginia 23502 |
Accord Clinical Research, LLC | Port Orange, Florida 32129 |
Mid Hudson Medical Research, PLLC | New Windsor, New York 12553 |
Coastal Carolina Research Center | Mt. Pleasant, South Carolina 29464 |
Santa Monica Research Institute | Santa Monica, California 90404 |
New Orleans Research Institute | Metairie, Louisiana 70006 |
Louisiana Research Center | Shreveport, Louisiana 71103 |
Metropolitan Gastroenterology Group | Chevy Chase, Maryland 20815 |
Innovative Clinical Research Institute | Downey, California 90241 |
Achieve Clinical Research LLC | Birmingham, Alabama 35216 |
Zasa Clinical Research | Boyton Beach, Florida 33472 |
Center for Gastrointestinal Disorders | Hollywood, Florida 33021 |
Advance Medical Research Service Corp. | Miami, Florida 33165 |
Stedman Clinical Trials, LLC | Tampa, Florida 33613 |
Commonwealth Clinical Trials | Brockton, Massachusetts 02302 |
Troy Gastroenterology PC Center for Digestive Health | Troy, Michigan 48098 |
Binghampton Gastroenterology Associates | Binghampton, New York 13903 |
Bassett Healthcare Center | Cooperstown, New York 13326 |
New York Gastroenterology Associates, LLP | New York, New York 10075 |
Montefiore - Einstein Cancer Care Center | New York, New York 10641 |
Piedmont Medical Research Associates, LLC | Winston-Salem, North Carolina 27103 |
Lillestol Research, LLC | Fargo, North Dakota 58103 |
Gastroenterology Research Consultants of Greater Cincinnati | Cincinnati, Ohio 45242 |
Independent Clinical Research, LLC | Carrolton, Texas 75010 |
Dean Foundation Medical Research | Madison, Wisconsin 53715 |
Charlotte Gastroenterology and Hepatology, PLLC | Charlotte, North Carolina 28207 |
West Gastroenterology Medical Group | Los Angeles, California 90813 |
Greater Arizona Gastroenterology Associates | Casa Grande, Arizona 85122 |
Futura Research, Inc. | Montebello, California 90640 |
Southern California Research Institute Medical Group, Inc. | Murrieta, California 92502 |
Diverse Research Solutions, LLC | Oxnard, California 93030 |
Inland Gastroenterology Medical Associates, Inc. | Redlands, California 92374 |
United Clinical Research, Corp. | Miami, Florida 33155 |
Palm Springs Research Institute, Inc | Miami, Florida 33126 |
Physicians Regional Medical Center | Naples, Florida 34119 |
PMI Research | Atlanta, Georgia 30312 |
Saint Francis Cancer Care Center | Indianapolis, Indiana 46237 |
Atlantic Medical Group | Kinston, North Carolina 28501 |
Clinical Trials of America, Inc. | Eugene, Oregon 97401 |
Bux-Mont Gastroenterology Associates | Sellersville, Pennsylvania 18960 |
Seton Family Hospital | Austin, Texas 78723 |
Clinical Trial Network | Houston, Texas 77074 |
Digestive Associates of Houston | Spring, Texas 77386 |
Spring Gastroenterology | Spring, Texas 77386 |