Head to Head Study Epi proColon and FIT

August 3, 2015 updated by: Epigenomics, Inc

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

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research of Puerto Rico
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research LLC
    • Arizona
      • Casa Grande, Arizona, United States, 85122
        • Greater Arizona Gastroenterology Associates
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research
    • California
      • Laguna Hills, California, United States, 92653
        • South Orange County Surgical Medical Group
      • Los Angeles, California, United States, 90015
        • HealthCare Partners Medical Group
      • Montebello, California, United States, 90640
        • Futura Research, Inc.
      • Murrieta, California, United States, 92502
        • Southern California Research Institute Medical Group, Inc.
      • Murrieta, California, United States, 92502
        • West Gastroenterology Medical Group
      • Oxnard, California, United States, 93030
        • Diverse Research Solutions, LLC
      • Redlands, California, United States, 92374
        • Inland Gastroenterology Medical Associates, Inc.
      • Santa Monica, California, United States, 90404
        • Santa Monica Research Institute
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital Cancer Center
    • Florida
      • Boyton Beach, Florida, United States, 33472
        • Zasa Clinical Research
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Hollywood, Florida, United States, 33021
        • Center for Gastrointestinal Disorders
      • Miami, Florida, United States, 33155
        • United Clinical Research, Corp.
      • Miami, Florida, United States, 33126
        • Palm Springs Research Institute, Inc
      • Miami, Florida, United States, 33165
        • Advance Medical Research Service Corp.
      • Naples, Florida, United States, 34119
        • Physicians Regional Medical Center
      • Palm Harbor, Florida, United States
        • Advance Medical Research Group
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research, LLC
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • PMI Research
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd.
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Saint Francis Cancer Care Center
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Trover Center for Clinical Studies
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Trials
    • Michigan
      • Novi, Michigan, United States, 48377
        • Detroit Clinical Research Center
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
      • Troy, Michigan, United States, 48098
        • Troy Gastroenterology PC Center for Digestive Health
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • New York
      • Binghampton, New York, United States, 13903
        • Binghampton Gastroenterology Associates
      • Brooklyn, New York, United States, 11206
        • Life Medi-research and Management
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Center
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • New York, New York, United States, 10075
        • New York Gastroenterology Associates, LLP
      • New York, New York, United States, 10641
        • Montefiore - Einstein Cancer Care Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology, PLLC
      • Charlotte, North Carolina, United States, 28226
        • Carolina Digestive Health Associates
      • Kinston, North Carolina, United States, 28501
        • Atlantic Medical Group
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates, LLC
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Legacy Pharma Research
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Gastroenterology Research Consultants of Greater Cincinnati
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Eugene, Oregon, United States, 97401
        • Clinical Trials of America, Inc.
    • Pennsylvania
      • Sellersville, Pennsylvania, United States, 18960
        • Bux-Mont Gastroenterology Associates
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates
    • Texas
      • Carrolton, Texas, United States, 75010
        • Independent Clinical Research, LLC
      • Spring, Texas, United States, 77386
        • Spring Gastroenterology
      • Spring, Texas, United States, 77386
        • Digestive Associates of Houston
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Salt Lake Research
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
    • Washington
      • Tacoma, Washington, United States, 98405
        • Multicare Health Systems, Medical Oncology
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Foundation Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
At completion of testing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juergen Beck, MD, Epigenomics, Inc
  • Study Director: Neil Mucci, Epigenomics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

July 1, 2014

More Information

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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