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Brief Title: Longitudinal Performance of Epi proColon
Official Title: Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
Study ID: NCT03218423
Brief 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.
Detailed 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.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Veterans Affairs San Diego Healthcare System, San Diego, California, United States
Beaumont Health System, Royal Oak, Michigan, United States
Rutgers University Hospital, New Brunswick, New Jersey, United States
Duke University, Durham, North Carolina, United States
Geisinger Health System, Danville, Pennsylvania, United States
West Virginia University, Morgantown, West Virginia, United States
Name: Theo deVos, PhD
Affiliation: Epigenomics, Inc
Role: STUDY_DIRECTOR