Head to Head Study Epi proColon and FIT

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580540
• Other study ID #: Epigenomics-SPR 0022
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: August 3, 2015
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Epigenomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 84 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Puerto Rico	Clinical Research of Puerto Rico	San Juan
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	PMI Research	Atlanta	Georgia
United States	Bend Memorial Clinic	Bend	Oregon
United States	Binghampton Gastroenterology Associates	Binghampton	New York
United States	Achieve Clinical Research LLC	Birmingham	Alabama
United States	Legacy Pharma Research	Bismarck	North Dakota
United States	Zasa Clinical Research	Boyton Beach	Florida
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Commonwealth Clinical Trials	Brockton	Massachusetts
United States	Life Medi-research and Management	Brooklyn	New York
United States	Independent Clinical Research, LLC	Carrolton	Texas
United States	Greater Arizona Gastroenterology Associates	Casa Grande	Arizona
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC	Charlotte	North Carolina
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Metropolitan Gastroenterology Group	Chevy Chase	Maryland
United States	Gastroenterology Research Consultants of Greater Cincinnati	Cincinnati	Ohio
United States	Bassett Healthcare Center	Cooperstown	New York
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Clinical Trials of America, Inc.	Eugene	Oregon
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Center for Gastrointestinal Disorders	Hollywood	Florida
United States	Saint Francis Cancer Care Center	Indianapolis	Indiana
United States	Research Medical Center	Kansas City	Missouri
United States	Gastroenterology Associates	Kingsport	Tennessee
United States	Atlantic Medical Group	Kinston	North Carolina
United States	South Orange County Surgical Medical Group	Laguna Hills	California
United States	Healthcare Partners Medical Group	Los Angeles	California
United States	Dean Foundation Medical Research	Madison	Wisconsin
United States	University of Wisconsin	Madison	Wisconsin
United States	Trover Center for Clinical Studies	Madisonville	Kentucky
United States	New Orleans Research Institute	Metairie	Louisiana
United States	Advance Medical Research Service Corp.	Miami	Florida
United States	Palm Springs Research Institute, Inc	Miami	Florida
United States	United Clinical Research, Corp.	Miami	Florida
United States	Middlesex Hospital Cancer Center	Middletown	Connecticut
United States	Futura Research, Inc.	Montebello	California
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Southern California Research Institute Medical Group, Inc.	Murrieta	California
United States	West Gastroenterology Medical Group	Murrieta	California
United States	Physicians Regional Medical Center	Naples	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Mid Hudson Medical Research, PLLC	New Windsor	New York
United States	Montefiore - Einstein Cancer Care Center	New York	New York
United States	New York Gastroenterology Associates, LLP	New York	New York
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Detroit Clinical Research Center	Novi	Michigan
United States	Diverse Research Solutions, LLC	Oxnard	California
United States	Advance Medical Research Group	Palm Harbor	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Inland Gastroenterology Medical Associates, Inc.	Redlands	California
United States	Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Salt Lake Research	Salt Lake City	Utah
United States	Santa Monica Research Institute	Santa Monica	California
United States	Bux-Mont Gastroenterology Associates	Sellersville	Pennsylvania
United States	Louisiana Research Center	Shreveport	Louisiana
United States	Digestive Associates of Houston	Spring	Texas
United States	Spring Gastroenterology	Spring	Texas
United States	Springfield Clinic	Springfield	Illinois
United States	Multicare Health Systems, Medical Oncology	Tacoma	Washington
United States	Stedman Clinical Trials, LLC	Tampa	Florida
United States	Troy Gastroenterology PC Center for Digestive Health	Troy	Michigan
United States	Visions Clinical Research	Tucson	Arizona
United States	Innovative Clinical Research Institute	Whittier	California
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina
United States	Piedmont Medical Research Associates, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No