Head to Head Study Epi proColon and FIT

• ClinicalTrials.gov Identifier: NCT01580540
• Recruitment Status: Completed
• First Posted: April 19, 2012
• Last Update Posted: August 4, 2015
• Sponsor: Epigenomics, Inc
• 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
• 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.

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

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
• Current Responsible Party: Epigenomics, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Epigenomics, Inc
• Original Study Sponsor: Same as current
• 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