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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


N/A
50 Years
84 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control

Outcome Measure:

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.

Outcome Time Frame:

At completion of testing.

Safety Issue:

No

Principal Investigator

Juergen Beck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Epigenomics, Inc

Authority:

United States: Institutional Review Board

Study ID:

Epigenomics-SPR 0022

NCT ID:

NCT01580540

Start Date:

March 2012

Completion Date:

November 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location

Ochsner Clinic Foundation New Orleans, Louisiana  70121
Middlesex Hospital Cancer Center Middletown, Connecticut  06457
Research Medical Center Kansas City, Missouri  64132
Gastroenterology Associates of Fairfield County Bridgeport, Connecticut  06606
Asheville Gastroenterology Associates Asheville, North Carolina  28801
Bend Memorial Clinic Bend, Oregon  97701
Salt Lake Research Salt Lake City, Utah  84124
University of Wisconsin Madison,, Wisconsin  53792-5666
Healthcare Partners Medical Group Torrance, California  90503
The Christ Hospital Cincinnati, Ohio  45219
Springfield Clinic Springfield, Illinois  62703
Clinical Research Associates of Tidewater Norfolk, Virginia  23507
Trover Center for Clinical Studies Madisonville, Kentucky  42431
Gastroenterology Associates Kingsport, Tennessee  37660
Gastroenterology Associates of Tidewater Chesapeake, Virginia  23320
Visions Clinical Research Tucson, Arizona  85712
Legacy Pharma Research Bismarck, North Dakota  58501
Carolina Digestive Health Associates Harrisburg, North Carolina  28075
Beaumont Hospital Royal Oak, Michigan  48073
Rockford Gastroenterology Associates, Ltd. Rockford, Illinois  61107
Digestive Health Specialists, PA Winston Salem, North Carolina  27103
South Orange County Surgical Medical Group Laguna Hills, California  92653
Detroit Clinical Research Center Farmington Hills, Michigan  48336
Digestive and Liver Disease Specialists Norfolk, Virginia  23502
Accord Clinical Research, LLC Port Orange, Florida  32129
Mid Hudson Medical Research, PLLC New Windsor, New York  12553
Coastal Carolina Research Center Mt. Pleasant, South Carolina  29464
Santa Monica Research Institute Santa Monica, California  90404
New Orleans Research Institute Metairie, Louisiana  70006
Louisiana Research Center Shreveport, Louisiana  71103
Metropolitan Gastroenterology Group Chevy Chase, Maryland  20815
Innovative Clinical Research Institute Downey, California  90241
Achieve Clinical Research LLC Birmingham, Alabama  35216
Zasa Clinical Research Boyton Beach, Florida  33472
Center for Gastrointestinal Disorders Hollywood, Florida  33021
Advance Medical Research Service Corp. Miami, Florida  33165
Stedman Clinical Trials, LLC Tampa, Florida  33613
Commonwealth Clinical Trials Brockton, Massachusetts  02302
Troy Gastroenterology PC Center for Digestive Health Troy, Michigan  48098
Binghampton Gastroenterology Associates Binghampton, New York  13903
Bassett Healthcare Center Cooperstown, New York  13326
New York Gastroenterology Associates, LLP New York, New York  10075
Montefiore - Einstein Cancer Care Center New York, New York  10641
Piedmont Medical Research Associates, LLC Winston-Salem, North Carolina  27103
Lillestol Research, LLC Fargo, North Dakota  58103
Gastroenterology Research Consultants of Greater Cincinnati Cincinnati, Ohio  45242
Independent Clinical Research, LLC Carrolton, Texas  75010
Dean Foundation Medical Research Madison, Wisconsin  53715
Charlotte Gastroenterology and Hepatology, PLLC Charlotte, North Carolina  28207
West Gastroenterology Medical Group Los Angeles, California  90813
Greater Arizona Gastroenterology Associates Casa Grande, Arizona  85122
Futura Research, Inc. Montebello, California  90640
Southern California Research Institute Medical Group, Inc. Murrieta, California  92502
Diverse Research Solutions, LLC Oxnard, California  93030
Inland Gastroenterology Medical Associates, Inc. Redlands, California  92374
United Clinical Research, Corp. Miami, Florida  33155
Palm Springs Research Institute, Inc Miami, Florida  33126
Physicians Regional Medical Center Naples, Florida  34119
PMI Research Atlanta, Georgia  30312
Saint Francis Cancer Care Center Indianapolis, Indiana  46237
Atlantic Medical Group Kinston, North Carolina  28501
Clinical Trials of America, Inc. Eugene, Oregon  97401
Bux-Mont Gastroenterology Associates Sellersville, Pennsylvania  18960
Seton Family Hospital Austin, Texas  78723
Clinical Trial Network Houston, Texas  77074
Digestive Associates of Houston Spring, Texas  77386
Spring Gastroenterology Spring, Texas  77386