Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
336 participants
OBSERVATIONAL
2012-03-31
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
Study Groups
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Group A, subjects with colorectal cancer
Subjects between ages 50 and 84 identified to have CRC. Blood and stool specimens are collected and tested after colonoscopy and prior to surgery or other interventions.
No interventions assigned to this group
Group B, subjects without CRC
Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
50 Years
84 Years
ALL
Yes
Sponsors
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Epigenomics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Juergen Beck, MD
Role: PRINCIPAL_INVESTIGATOR
Epigenomics, Inc
Neil Mucci
Role: STUDY_DIRECTOR
Epigenomics, Inc
Locations
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Achieve Clinical Research LLC
Birmingham, Alabama, United States
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
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Saint Francis Cancer Care Center
Indianapolis, Indiana, United States
Trover Center for Clinical Studies
Madisonville, Kentucky, United States
New Orleans Research Institute
Metairie, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States
Commonwealth Clinical Trials
Brockton, Massachusetts, United States
Detroit Clinical Research Center
Novi, Michigan, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Binghampton Gastroenterology Associates
Binghampton, New York, United States
Life Medi-research and Management
Brooklyn, New York, United States
Bassett Healthcare Center
Cooperstown, New York, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
New York Gastroenterology Associates, LLP
New York, New York, United States
Montefiore - Einstein Cancer Care Center
New York, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Atlantic Medical Group
Kinston, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
Piedmont Medical Research Associates, LLC
Winston-Salem, North Carolina, United States
Legacy Pharma Research
Bismarck, North Dakota, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States
Bend Memorial Clinic
Bend, Oregon, United States
Clinical Trials of America, Inc.
Eugene, Oregon, United States
Bux-Mont Gastroenterology Associates
Sellersville, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Independent Clinical Research, LLC
Carrolton, Texas, United States
Digestive Associates of Houston
Spring, Texas, United States
Spring Gastroenterology
Spring, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Multicare Health Systems, Medical Oncology
Tacoma, Washington, United States
Dean Foundation Medical Research
Madison, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Clinical Research of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.
Other Identifiers
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Epigenomics-SPR 0022
Identifier Type: -
Identifier Source: org_study_id
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