Clinical trial NCT01580540: Head to Head Study Epi proColon and FIT
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 336
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from gastroenterology clinics and surgical centers in the United States.

Brief 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.

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 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

Primary outcomes:
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.
timeFrame: At completion of testing.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research LLC
state: Alabama
city: Casa Grande
country: United States
facility: Greater Arizona Gastroenterology Associates
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Los Angeles
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Montebello
country: United States
facility: Futura Research, Inc.
state: California
city: Murrieta
country: United States
facility: Southern California Research Institute Medical Group, Inc.
state: California
city: Murrieta
country: United States
facility: West Gastroenterology Medical Group
state: California
city: Oxnard
country: United States
facility: Diverse Research Solutions, LLC
state: California
city: Redlands
country: United States
facility: Inland Gastroenterology Medical Associates, Inc.
state: California
city: Santa Monica
country: United States
facility: Santa Monica Research Institute
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Hospital Cancer Center
state: Connecticut
city: Boyton Beach
country: United States
facility: Zasa Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Center for Gastrointestinal Disorders
state: Florida
city: Miami
country: United States
facility: Palm Springs Research Institute, Inc
state: Florida
city: Miami
country: United States
facility: United Clinical Research, Corp.
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Service Corp.
state: Florida
city: Naples
country: United States
facility: Physicians Regional Medical Center
state: Florida
city: Palm Harbor
country: United States
facility: Advance Medical Research Group
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: PMI Research
state: Georgia
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Saint Francis Cancer Care Center
state: Indiana
city: Madisonville
country: United States
facility: Trover Center for Clinical Studies
state: Kentucky
city: Metairie
country: United States
facility: New Orleans Research Institute
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Trials
state: Massachusetts
city: Novi
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Troy Gastroenterology PC Center for Digestive Health
state: Michigan
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Binghampton
country: United States
facility: Binghampton Gastroenterology Associates
state: New York
city: Brooklyn
country: United States
facility: Life Medi-research and Management
state: New York
city: Cooperstown
country: United States
facility: Bassett Healthcare Center
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates, LLP
state: New York
city: New York
country: United States
facility: Montefiore - Einstein Cancer Care Center
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology, PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Kinston
country: United States
facility: Atlantic Medical Group
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates, LLC
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Eugene
country: United States
facility: Clinical Trials of America, Inc.
state: Oregon
city: Sellersville
country: United States
facility: Bux-Mont Gastroenterology Associates
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Carrolton
country: United States
facility: Independent Clinical Research, LLC
state: Texas
city: Spring
country: United States
facility: Digestive Associates of Houston
state: Texas
city: Spring
country: United States
facility: Spring Gastroenterology
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Tacoma
country: United States
facility: Multicare Health Systems, Medical Oncology
state: Washington
city: Madison
country: United States
facility: Dean Foundation Medical Research
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Clinical Research of Puerto Rico
Study officials:
affiliation: Epigenomics, Inc
name: Juergen Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Epigenomics, Inc
name: Neil Mucci
role: STUDY_DIRECTOR
References:
citation: Johnson DA, Barclay RL, Mergener K, Weiss G, Konig T, Beck J, Potter NT. Plasma Septin9 versus fecal immunochemical testing for colorectal cancer screening: a prospective multicenter study. PLoS One. 2014 Jun 5;9(6):e98238. doi: 10.1371/journal.pone.0098238. eCollection 2014.