Blood-based colorectal cancer (CRC) screening implementation into clinical practice in the outpatient clinical setting in the Appalachian highlands.

Abstract

TPS10622 Background: Maximizing colorectal cancer (CRC) screening participation relies on tests that are acceptable, accessible, and patient-centered. While colonoscopy or stool-based tests have traditionally been the standard of care (SOC), they often present challenges related to timely completion and patient adherence. Blood-based tests (BBTs) detecting circulating tumor DNA (ctDNA) offer a quicker, less invasive alternative to previous methods of screening. While the BBTs exhibit comparable sensitivity and specificity to the existing noninvasive SOC, their user-friendly nature holds the potential to enhance adherence. This study aims to explore the implementation of a BBT and its impact on patient acceptability and adherence to CRC screening. The study focuses on the Appalachian population, known for higher CRC incidence1 and mortality rates2 compared to the general US population. Methods: The trial is being conducted at two primary care clinics. It consists of two phases over a 6-month period, aiming to enroll over 300 patients. Participants aged 45-84 years, identified as average risk for CRC according to USPSTF guidelines, and who have opted to be screened for CRC and are willing to participate in the study will be eligible. Exclusion criteria consist of higher-than-average risk for CRC according to the USPSTF standards. During Phase 1 (control period), patients meeting inclusion criteria will be offered SOC (colonoscopy and/or stool-based test) for 3 months followed by Phase 2 (intervention period) where a BBT in addition to SOC will be offered for another 3 months. Informed consent will be obtained prior to any study procedures. The BBT used for the study has a sensitivity of 83% and specificity of 90%. Patients who agree to BBT will undergo a single blood draw of 40 mL. Phase 1 has concluded with enrollment of 75 patients, while Phase 2 is currently ongoing and actively recruiting participants. Upon completion of study, an EMR review will be conducted on participants to evaluate screening rates before and after implementing the BBT and to assess adherence. The primary endpoint of the study involves calculating the total number of consented patients who opted for and completed either BBT or SOC during the interventional period compared to the total number of patients who opted for SOC during the control period. Final data analysis is expected by July 2024.