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Completed No phase listed Observational Accepts healthy volunteers

Head to Head Study Epi proColon and FIT

ClinicalTrials.gov ID: NCT01580540

Public ClinicalTrials.gov record NCT01580540. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01580540
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Epigenomics, Inc
Industry
Enrollment
336 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
50 Years to 84 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2012 (Type not available)
Primary completion
Nov 2012 (Actual)
Completion
Nov 2012 (Actual)
Last update posted
Aug 4, 2015

2012

United States locations

U.S. sites
69
U.S. states
27
U.S. cities
60
Facility City State ZIP Site status
Achieve Clinical Research LLC Birmingham Alabama 35216 —
Greater Arizona Gastroenterology Associates Casa Grande Arizona 85122 —
Visions Clinical Research Tucson Arizona 85712 —
South Orange County Surgical Medical Group Laguna Hills California 92653 —
Healthcare Partners Medical Group Los Angeles California 90015 —
Futura Research, Inc. Montebello California 90640 —
Southern California Research Institute Medical Group, Inc. Murrieta California 92502 —
West Gastroenterology Medical Group Murrieta California 92502 —
Diverse Research Solutions, LLC Oxnard California 93030 —
Inland Gastroenterology Medical Associates, Inc. Redlands California 92374 —
Santa Monica Research Institute Santa Monica California 90404 —
Innovative Clinical Research Institute Whittier California 90603 —
Gastroenterology Associates of Fairfield County Bridgeport Connecticut 06606 —
Middlesex Hospital Cancer Center Middletown Connecticut 06457 —
Zasa Clinical Research Boyton Beach Florida 33472 —
Clinical Research of South Florida Coral Gables Florida 33134 —
Center for Gastrointestinal Disorders Hollywood Florida 33021 —
Palm Springs Research Institute, Inc Miami Florida 33126 —
United Clinical Research, Corp. Miami Florida 33155 —
Advance Medical Research Service Corp. Miami Florida 33165 —
Physicians Regional Medical Center Naples Florida 34119 —
Advance Medical Research Group Palm Harbor Florida — —
Accord Clinical Research, LLC Port Orange Florida 32129 —
Stedman Clinical Trials, LLC Tampa Florida 33613 —
PMI Research Atlanta Georgia 30312 —
Rockford Gastroenterology Associates, Ltd. Rockford Illinois 61107 —
Springfield Clinic Springfield Illinois 62703 —
Saint Francis Cancer Care Center Indianapolis Indiana 46237 —
Trover Center for Clinical Studies Madisonville Kentucky 42431 —
New Orleans Research Institute Metairie Louisiana 70006 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
Louisiana Research Center Shreveport Louisiana 71103 —
Metropolitan Gastroenterology Group Chevy Chase Maryland 20815 —
Commonwealth Clinical Trials Brockton Massachusetts 02302 —
Detroit Clinical Research Center Novi Michigan 48377 —
Beaumont Hospital Royal Oak Michigan 48073 —
Troy Gastroenterology PC Center for Digestive Health Troy Michigan 48098 —
Research Medical Center Kansas City Missouri 64132 —
Binghampton Gastroenterology Associates Binghampton New York 13903 —
Life Medi-research and Management Brooklyn New York 11206 —
Bassett Healthcare Center Cooperstown New York 13326 —
Mid Hudson Medical Research, PLLC New Windsor New York 12553 —
New York Gastroenterology Associates, LLP New York New York 10075 —
Montefiore - Einstein Cancer Care Center New York New York 10641 —
Asheville Gastroenterology Associates Asheville North Carolina 28801 —
Charlotte Gastroenterology and Hepatology, PLLC Charlotte North Carolina 28207 —
Carolina Digestive Health Associates Charlotte North Carolina 28226 —
Atlantic Medical Group Kinston North Carolina 28501 —
Digestive Health Specialists, PA Winston-Salem North Carolina 27103 —
Piedmont Medical Research Associates, LLC Winston-Salem North Carolina 27103 —
Legacy Pharma Research Bismarck North Dakota 58501 —
Lillestol Research, LLC Fargo North Dakota 58103 —
Gastroenterology Research Consultants of Greater Cincinnati Cincinnati Ohio 45242 —
Bend Memorial Clinic Bend Oregon 97701 —
Clinical Trials of America, Inc. Eugene Oregon 97401 —
Bux-Mont Gastroenterology Associates Sellersville Pennsylvania 18960 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
ClinSearch, LLC Chattanooga Tennessee 37421 —
Gastroenterology Associates Kingsport Tennessee 37660 —
Independent Clinical Research, LLC Carrolton Texas 75010 —
Digestive Associates of Houston Spring Texas 77386 —
Spring Gastroenterology Spring Texas 77386 —
Salt Lake Research Salt Lake City Utah 84107 —
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320 —
Digestive and Liver Disease Specialists Norfolk Virginia 23502 —
Clinical Research Associates of Tidewater Norfolk Virginia 23507 —
Multicare Health Systems, Medical Oncology Tacoma Washington 98405 —
Dean Foundation Medical Research Madison Wisconsin 53715 —
University of Wisconsin Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01580540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2015 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01580540 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →