Design of a hybrid site and decentralized clinical research study of an early detection blood test for colorectal cancer.

Abstract

TPS245 Background: Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related death in the United States of America. CRC screening improves mortality rates, but current CRC screening methodologies, such as colonoscopy and stool-based tests, are plagued by low compliance rates. Preliminary studies evaluating the performance of our blood-based CRC screening test demonstrated high sensitivity and specificity in CRC patients across all stages and among screen-detected cases. Clinical validation is in progress. We describe the ongoing, prospective, observational, sample collection clinical study, FIND-CRC (NCT07046585), that uses a hybrid clinic-based and decentralized approach to efficiently enroll a representative average-risk population. Methods: The study opened in May 2025 and aims to enroll 25,000 subjects. We aim to evaluate a blood-based CRC screening test by calculating the sensitivity for CRC detection and the specificity for advanced neoplasia (AN). Secondary aims are to evaluate the sensitivity of APL detection, the sensitivity for high-risk advanced precancerous lesion (APL) detection, and the specificity of negative findings. The study includes participants aged ≥40 years at time of consent, planning/intending to undergo a standard of care screening colonoscopy, able to tolerate venipuncture for research draw(s), able and willing to provide blood samples within 120 days prior to bowel preparation and colonoscopy, able to comply with the study visit and study requirements, and having a signed informed consent document prior to participation. Exclusion criteria are prior malignancy, diagnostic colonoscopy in the past 9 years or any other CRC screening tests within guideline-recommended intervals, or a personal history of hereditary cancer syndromes associated with elevated CRC risk. A hybrid approach utilizing decentralized and clinic-based study sites has been implemented to reach a diverse study cohort representative of the average-risk US population. The decentralized approach implements several non-traditional recruitment outreach efforts, including engaging a pharmacy provider to whom individuals have previously consented to receive messages or notifications, digital advertisements, referral letters from healthcare professionals, and partnerships with community advocacy groups. Interested participants have access to a web link or QR code to initiate screening for the study. After informed consent and enrollment, participants may schedule a blood draw based on their availability. Participants are considered evaluable if they meet the inclusion criteria, provide informed consent, complete the screening colonoscopy, and have medical records and pathology reports provided. Clinical trial information: NCT07046585 .