Head to Head Study Epi proColon and FIT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT01580540
First received: April 17, 2012
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Epigenomics, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma


Estimated Enrollment: 300
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects are recruited from gastroenterology clinics and surgical centers in the United States.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580540

  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research LLC
Birmingham, Alabama, United States, 35216
United States, Arizona
Greater Arizona Gastroenterology Associates
Casa Grande, Arizona, United States, 85122
Visions Clinical Research
Tucson, Arizona, United States, 85712
United States, California
South Orange County Surgical Medical Group
Laguna Hills, California, United States, 92653
Healthcare Partners Medical Group
Los Angeles, California, United States, 90015
Futura Research, Inc.
Montebello, California, United States, 90640
West Gastroenterology Medical Group
Murrieta, California, United States, 92502
Southern California Research Institute Medical Group, Inc.
Murrieta, California, United States, 92502
Diverse Research Solutions, LLC
Oxnard, California, United States, 93030
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, United States, 92374
Santa Monica Research Institute
Santa Monica, California, United States, 90404
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States, 06457
United States, Florida
Zasa Clinical Research
Boyton Beach, Florida, United States, 33472
Center for Gastrointestinal Disorders
Hollywood, Florida, United States, 33021
Advance Medical Research Service Corp.
Miami, Florida, United States, 33165
United Clinical Research, Corp.
Miami, Florida, United States, 33155
Palm Springs Research Institute, Inc
Miami, Florida, United States, 33126
Physicians Regional Medical Center
Naples, Florida, United States, 34119
Accord Clinical Research, LLC
Port Orange, Florida, United States, 32129
Stedman Clinical Trials, LLC
Tampa, Florida, United States, 33613
United States, Georgia
PMI Research
Atlanta, Georgia, United States, 30312
United States, Illinois
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States, 61107
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Indiana
Saint Francis Cancer Care Center
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Trover Center for Clinical Studies
Madisonville, Kentucky, United States, 42431
United States, Louisiana
New Orleans Research Institute
Metairie, Louisiana, United States, 70006
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Louisiana Research Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Commonwealth Clinical Trials
Brockton, Massachusetts, United States, 02302
United States, Michigan
Detroit Clinical Research Center
Novi, Michigan, United States, 48377
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Troy Gastroenterology PC Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, New York
Binghampton Gastroenterology Associates
Binghampton, New York, United States, 13903
Bassett Healthcare Center
Cooperstown, New York, United States, 13326
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States, 12553
New York Gastroenterology Associates, LLP
New York, New York, United States, 10075
Montefiore - Einstein Cancer Care Center
New York, New York, United States, 10641
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28226
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States, 28207
Atlantic Medical Group
Kinston, North Carolina, United States, 28501
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
Piedmont Medical Research Associates, LLC
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Legacy Pharma Research
Bismarck, North Dakota, United States, 58501
Lillestol Research, LLC
Fargo, North Dakota, United States, 58103
United States, Ohio
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States, 45242
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Clinical Trials of America, Inc.
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Bux-Mont Gastroenterology Associates
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Gastroenterology Associates
Kingsport, Tennessee, United States, 37660
United States, Texas
Seton Family Hospital
Austin, Texas, United States, 78723
Independent Clinical Research, LLC
Carrolton, Texas, United States, 75010
Clinical Trial Network
Houston, Texas, United States, 77074
Digestive Associates of Houston
Spring, Texas, United States, 77386
Spring Gastroenterology
Spring, Texas, United States, 77386
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Dean Foundation Medical Research
Madison, Wisconsin, United States, 53715
University of Wisconsin
Madison, Wisconsin, United States, 53792
Puerto Rico
Clinical Research of Puerto Rico
San Juan, Puerto Rico, 00909-1711
Sponsors and Collaborators
Epigenomics, Inc
Investigators
Principal Investigator: Juergen Beck, MD Epigenomics, Inc
Study Director: Neil Mucci Epigenomics, Inc
  More Information

No publications provided

Responsible Party: Epigenomics, Inc
ClinicalTrials.gov Identifier: NCT01580540     History of Changes
Other Study ID Numbers: Epigenomics-SPR 0022
Study First Received: April 17, 2012
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 26, 2014