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
|Condition or disease|
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|
|Actual Enrollment :||336 participants|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
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.
- 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. ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580540
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|Principal Investigator:||Juergen Beck, MD||Epigenomics, Inc|
|Study Director:||Neil Mucci||Epigenomics, Inc|