Head to Head Study Epi proColon and FIT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT01580540
First received: April 17, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
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

Resource links provided by NLM:


Further study details as provided by Epigenomics, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma


Enrollment: 336
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

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

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects are recruited from gastroenterology clinics and surgical centers in the United States.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580540

  Show 70 Study Locations
Sponsors and Collaborators
Epigenomics, Inc
Investigators
Principal Investigator: Juergen Beck, MD Epigenomics, Inc
Study Director: Neil Mucci Epigenomics, Inc
  More Information

No publications provided

Responsible Party: Epigenomics, Inc
ClinicalTrials.gov Identifier: NCT01580540     History of Changes
Other Study ID Numbers: Epigenomics-SPR 0022
Study First Received: April 17, 2012
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014