- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580540
Head to Head Study Epi proColon and FIT
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00909-1711
- Clinical Research of Puerto Rico
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Alabama
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Birmingham, Alabama, United States, 35216
- Achieve Clinical Research LLC
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Arizona
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Casa Grande, Arizona, United States, 85122
- Greater Arizona Gastroenterology Associates
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Tucson, Arizona, United States, 85712
- Visions Clinical Research
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California
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Laguna Hills, California, United States, 92653
- South Orange County Surgical Medical Group
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Los Angeles, California, United States, 90015
- HealthCare Partners Medical Group
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Montebello, California, United States, 90640
- Futura Research, Inc.
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Murrieta, California, United States, 92502
- Southern California Research Institute Medical Group, Inc.
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Murrieta, California, United States, 92502
- West Gastroenterology Medical Group
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Oxnard, California, United States, 93030
- Diverse Research Solutions, LLC
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Redlands, California, United States, 92374
- Inland Gastroenterology Medical Associates, Inc.
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Santa Monica, California, United States, 90404
- Santa Monica Research Institute
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Whittier, California, United States, 90603
- Innovative Clinical Research Institute
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Gastroenterology Associates of Fairfield County
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Middletown, Connecticut, United States, 06457
- Middlesex Hospital Cancer Center
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Florida
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Boyton Beach, Florida, United States, 33472
- Zasa Clinical Research
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Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida
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Hollywood, Florida, United States, 33021
- Center for Gastrointestinal Disorders
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Miami, Florida, United States, 33155
- United Clinical Research, Corp.
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Miami, Florida, United States, 33126
- Palm Springs Research Institute, Inc
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Miami, Florida, United States, 33165
- Advance Medical Research Service Corp.
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Naples, Florida, United States, 34119
- Physicians Regional Medical Center
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Palm Harbor, Florida, United States
- Advance Medical Research Group
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Port Orange, Florida, United States, 32129
- Accord Clinical Research, LLC
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Tampa, Florida, United States, 33613
- Stedman Clinical Trials, LLC
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Georgia
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Atlanta, Georgia, United States, 30312
- PMI Research
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Illinois
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Rockford, Illinois, United States, 61107
- Rockford Gastroenterology Associates, Ltd.
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Springfield, Illinois, United States, 62703
- Springfield Clinic
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Indiana
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Indianapolis, Indiana, United States, 46237
- Saint Francis Cancer Care Center
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Kentucky
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Madisonville, Kentucky, United States, 42431
- Trover Center for Clinical Studies
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Louisiana
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Metairie, Louisiana, United States, 70006
- New Orleans Research Institute
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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Shreveport, Louisiana, United States, 71103
- Louisiana Research Center
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Maryland
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Chevy Chase, Maryland, United States, 20815
- Metropolitan Gastroenterology Group
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Massachusetts
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Brockton, Massachusetts, United States, 02302
- Commonwealth Clinical Trials
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Michigan
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Novi, Michigan, United States, 48377
- Detroit Clinical Research Center
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Troy, Michigan, United States, 48098
- Troy Gastroenterology PC Center for Digestive Health
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Missouri
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Kansas City, Missouri, United States, 64132
- Research Medical Center
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New York
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Binghampton, New York, United States, 13903
- Binghampton Gastroenterology Associates
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Brooklyn, New York, United States, 11206
- Life Medi-research and Management
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Cooperstown, New York, United States, 13326
- Bassett Healthcare Center
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New Windsor, New York, United States, 12553
- Mid Hudson Medical Research, PLLC
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New York, New York, United States, 10075
- New York Gastroenterology Associates, LLP
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New York, New York, United States, 10641
- Montefiore - Einstein Cancer Care Center
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North Carolina
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Asheville, North Carolina, United States, 28801
- Asheville Gastroenterology Associates
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Charlotte, North Carolina, United States, 28207
- Charlotte Gastroenterology and Hepatology, PLLC
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Charlotte, North Carolina, United States, 28226
- Carolina Digestive Health Associates
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Kinston, North Carolina, United States, 28501
- Atlantic Medical Group
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Winston-Salem, North Carolina, United States, 27103
- Digestive Health Specialists, PA
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Winston-Salem, North Carolina, United States, 27103
- Piedmont Medical Research Associates, LLC
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North Dakota
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Bismarck, North Dakota, United States, 58501
- Legacy Pharma Research
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Fargo, North Dakota, United States, 58103
- Lillestol Research, LLC
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Ohio
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Cincinnati, Ohio, United States, 45242
- Gastroenterology Research Consultants of Greater Cincinnati
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Oregon
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Bend, Oregon, United States, 97701
- Bend Memorial Clinic
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Eugene, Oregon, United States, 97401
- Clinical Trials of America, Inc.
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Pennsylvania
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Sellersville, Pennsylvania, United States, 18960
- Bux-Mont Gastroenterology Associates
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South Carolina
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Mt. Pleasant, South Carolina, United States, 29464
- Coastal Carolina Research Center
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- ClinSearch, LLC
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Kingsport, Tennessee, United States, 37660
- Gastroenterology Associates
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Texas
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Carrolton, Texas, United States, 75010
- Independent Clinical Research, LLC
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Spring, Texas, United States, 77386
- Spring Gastroenterology
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Spring, Texas, United States, 77386
- Digestive Associates of Houston
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Utah
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Salt Lake City, Utah, United States, 84107
- Salt Lake Research
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Virginia
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Chesapeake, Virginia, United States, 23320
- Gastroenterology Associates of Tidewater
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Norfolk, Virginia, United States, 23502
- Digestive and Liver Disease Specialists
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Norfolk, Virginia, United States, 23507
- Clinical Research Associates of Tidewater
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Washington
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Tacoma, Washington, United States, 98405
- Multicare Health Systems, Medical Oncology
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Madison, Wisconsin, United States, 53715
- Dean Foundation Medical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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Group B, subjects without CRC
Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: At completion of testing.
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At completion of testing.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juergen Beck, MD, Epigenomics, Inc
- Study Director: Neil Mucci, Epigenomics, Inc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epigenomics-SPR 0022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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