NCT01580540

Head to Head Study Epi proColon and FIT

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 336 (actual)
• Sponsor: Epigenomics, Inc · Industry
• Sex: All
• Age: 50 Years – 84 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-04-19
• Last updated: 2015-08-04

Locations

70 sites across 2 countries: United States, Puerto Rico