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Head to Head Study Epi proColon and FIT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580540
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Epigenomics, Inc

Tracking Information
First Submitted Date April 17, 2012
First Posted Date April 19, 2012
Last Update Posted Date August 4, 2015
Study Start Date March 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2012)
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. ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma
Sampling Method Non-Probability Sample
Study Population Subjects are recruited from gastroenterology clinics and surgical centers in the United States.
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Johnson DA, Barclay RL, Mergener K, Weiss G, König 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 29, 2014)
336
Original Estimated Enrollment
 (submitted: April 17, 2012)
300
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01580540
Other Study ID Numbers Epigenomics-SPR 0022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Epigenomics, Inc
Study Sponsor Epigenomics, Inc
Collaborators Not Provided
Investigators
Principal Investigator: Juergen Beck, MD Epigenomics, Inc
Study Director: Neil Mucci Epigenomics, Inc
PRS Account Epigenomics, Inc
Verification Date July 2014