Last updated on March 2020

Longitudinal Performance of Epi proColon

Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT03218423

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Duke University

Durham, NC United States
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Beaumont Health System

Royal Oak, MI United States
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West Virginia University

Morgantown, WV United States
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Rutgers University Hospital

New Brunswick, NJ United States
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Geisinger Health System

Danville, PA United States
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Recruitment Status: Open

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