The Ohio State University Guardant Shield Colorectal Cancer Screening Project

TPS3626 Background: Asymptomatic screening is an effective method for detecting early cancers when prognosis strongly depends on stage at time of diagnosis. Unscreened individuals often have a basic understanding of the importance and availability of colorectal cancer (CRC) screening but have concerns regarding the collection method of the currently available stool-based options or the invasiveness of direct visualization options that deter test completion. We hypothesize that offering a blood-based CRC screening test during a routine healthcare visit can increase screening adherence, especially within hard-to-reach populations and those hesitant about completing CRC screening. Methods: The Ohio State University Guardant Shield Colorectal Cancer Screening Project (NCT05716477) is a prospective study in the United States designed to recruit individuals who are currently engaging with mobile health clinics and are not up to date with CRC screening, with the aim of improving health in hard-to-reach populations. The study’s primary objective is to evaluate the acceptance of a commercially available blood-based CRC screening test (Shield, Guardant Health, USA) in individuals aged 45-84, who have existing appointments with a mobile health clinic, and are not up to date with guideline recommended CRC screening. The study team screens for eligibility criteria before the appointment and reaches out to the individual to begin the informed consent process. Positive blood-based test results will be triaged to colonoscopy for further evaluation. A post-study survey will be administered to consented individuals aimed to collect data on CRC screening knowledge which will be correlated to patient demographics and uptake. Acceptance will be defined as those approached and with completed specimen collection. Progress: The study initiated on October 25, 2022, with the first patient enrolled on December 20, 2022. Enrollment is expected to continue with a target enrollment of 300 individuals. Clinical trial information: NCT05716477 .