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Clinical Trial Summary

This study will evaluate longitudinal performance of Epi proColon with respect to test positivity, longitudinal adherence to Epi proColon screening, adherence to follow-up colonoscopy and diagnostic yield, as well as assay failure rates.


Clinical Trial Description

Epi proColon is blood based screening test for colorectal cancer that is FDA - PMA approved. It is indicated for average risk patients who are unwilling or unable to be screened with other recommended screening tests, including colonoscopy or fecal occult blood tests. The PERT study is designed to assess the test performance of Epi proColon when it is used annually for two consecutive years. Subjects enrolled in the study will be offered initial testing. Subjects with a positive result will be referred for colonoscopy. Subjects with a negative test result will be encouraged to be screened the following year. At the one year interval, test negative subjects will be reminded to be rescreened. Subjects with a positive test will be referred for colonoscopy, while subjects with a negative test will be be encouraged to participate in a screening program in subsequent years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03218423
Study type Observational
Source Epigenomics, Inc
Contact Theo deVos, PhD
Phone 2068832916
Email theo.devos@epigenomics.com
Status Recruiting
Phase
Start date August 18, 2017
Completion date January 2024

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