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Performance of Epi proColon in Repeated Testing (PERT) - Clinical Trial

What is the Purpose of this Study?

This study is testing an FDA-approved blood test that screens for colorectal cancer (CRC). It is being tested as an alternative for patients who are reluctant or who refuse to undergo screening colonoscopy or stool testing to screen for CRC. This study is confirming the accuracy of this blood test when used with repeated yearly testing.
What is the Condition Being Studied?
Colon cancer screening

Who Can Participate in the Study?

Patients aged 51-75 with average-risk of colon cancer (no family history, no personal history of polyps or CRC) who have declined CRC screening.

Patients must be willing and able to have a colonoscopy if the Epi proColon blood test is positive.

Age Group
Adults

What is Involved?

If you choose to join this study:

You will have a blood test called the Epi proColon test drawn at your first visit.

If this test is negative, you will come back in 1 year to have the same blood test repeated.

- If, at either of the 2 visits, your test is positive, you will need to have a colonoscopy.

The study team will help you set up this colonoscopy.

Study Details

Full Title
Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT)
Principal Investigator
Protocol Number
IRB: PRO00085544
NCT: NCT03218423
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698