Adherence to Minimally Invasive Testing

CompletedOBSERVATIONAL
Enrollment

490

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

June 30, 2015

Conditions
Colorectal Cancer
Interventions
DEVICE

Epi proColon Test

Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.

DEVICE

Fecal Immunochemical Test (FIT)

Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.

Trial Locations (2)

17822

Geisinger Clinic, Danville

97227

Kaiser Permanente Center for Health Research, Portland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Epigenomics, Inc

INDUSTRY

NCT02251782 - Adherence to Minimally Invasive Testing | Biotech Hunter | Biotech Hunter