NCT03218423

Longitudinal Performance of Epi proColon

Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: Epigenomics, Inc · Industry
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	Epi proColon	Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.

Timeline

• Start date: 2017-08-18
• Primary completion: 2023-08-01
• Completion: 2024-01-01
• First posted: 2017-07-14
• Last updated: 2021-11-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study