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
1 other identifier
observational
336
2 countries
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Shorter than P25 for all trials
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedAugust 4, 2015
July 1, 2014
8 months
April 17, 2012
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
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.
Group B, subjects without CRC
Subjects between ages 50 and 84 who provide stool and blood specimens prior to colonoscopy.
Eligibility Criteria
Subjects are recruited from gastroenterology clinics and surgical centers in the United States.
You may qualify if:
- Group A
- Willing and able to sign an informed consent and adhere to study requirements
- years of age at blood and stool sampling
- Colonoscopic diagnosis of colorectal carcinoma
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epigenomics, Inclead
Study Sites (70)
Achieve Clinical Research LLC
Birmingham, Alabama, 35216, United States
Greater Arizona Gastroenterology Associates
Casa Grande, Arizona, 85122, United States
Visions Clinical Research
Tucson, Arizona, 85712, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
Healthcare Partners Medical Group
Los Angeles, California, 90015, United States
Futura Research, Inc.
Montebello, California, 90640, United States
Southern California Research Institute Medical Group, Inc.
Murrieta, California, 92502, United States
West Gastroenterology Medical Group
Murrieta, California, 92502, United States
Diverse Research Solutions, LLC
Oxnard, California, 93030, United States
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, 92374, United States
Santa Monica Research Institute
Santa Monica, California, 90404, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, 06457, United States
Zasa Clinical Research
Boyton Beach, Florida, 33472, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Center for Gastrointestinal Disorders
Hollywood, Florida, 33021, United States
Palm Springs Research Institute, Inc
Miami, Florida, 33126, United States
United Clinical Research, Corp.
Miami, Florida, 33155, United States
Advance Medical Research Service Corp.
Miami, Florida, 33165, United States
Physicians Regional Medical Center
Naples, Florida, 34119, United States
Advance Medical Research Group
Palm Harbor, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
PMI Research
Atlanta, Georgia, 30312, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107, United States
Springfield Clinic
Springfield, Illinois, 62703, United States
Saint Francis Cancer Care Center
Indianapolis, Indiana, 46237, United States
Trover Center for Clinical Studies
Madisonville, Kentucky, 42431, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Louisiana Research Center
Shreveport, Louisiana, 71103, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Commonwealth Clinical Trials
Brockton, Massachusetts, 02302, United States
Detroit Clinical Research Center
Novi, Michigan, 48377, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan, 48098, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Binghampton Gastroenterology Associates
Binghampton, New York, 13903, United States
Life Medi-research and Management
Brooklyn, New York, 11206, United States
Bassett Healthcare Center
Cooperstown, New York, 13326, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553, United States
New York Gastroenterology Associates, LLP
New York, New York, 10075, United States
Montefiore - Einstein Cancer Care Center
New York, New York, 10641, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, 28207, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28226, United States
Atlantic Medical Group
Kinston, North Carolina, 28501, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Piedmont Medical Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Legacy Pharma Research
Bismarck, North Dakota, 58501, United States
Lillestol Research, LLC
Fargo, North Dakota, 58103, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, 45242, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Clinical Trials of America, Inc.
Eugene, Oregon, 97401, United States
Bux-Mont Gastroenterology Associates
Sellersville, Pennsylvania, 18960, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastroenterology Associates
Kingsport, Tennessee, 37660, United States
Independent Clinical Research, LLC
Carrolton, Texas, 75010, United States
Digestive Associates of Houston
Spring, Texas, 77386, United States
Spring Gastroenterology
Spring, Texas, 77386, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Multicare Health Systems, Medical Oncology
Tacoma, Washington, 98405, United States
Dean Foundation Medical Research
Madison, Wisconsin, 53715, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Clinical Research of Puerto Rico
San Juan, 00909-1711, Puerto Rico
Related Publications (1)
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.
PMID: 24901436DERIVED
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen Beck, MD
Epigenomics, Inc
- STUDY DIRECTOR
Neil Mucci
Epigenomics, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 19, 2012
Study Start
March 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
August 4, 2015
Record last verified: 2014-07