Expanding Diversity in Colorectal Cancer Studies with a Focus on Hispanic and Latino Participant Enrollment.

e13532 Background: Colorectal cancer (CRC) is a leading cause of cancer mortality among Hispanic and Latino groups (Hispanic/Latinx). Despite making up 18.9% of the U.S. population, Hispanic/Latinx representation is only 2.3%-3.9% of subjects in oncology trials, highlighting the need for diversity in CRC research. Freenome is developing a blood test (MyTectCRC) intended to provide a convenient and accessible option for CRC screening. Its clinical validation will be supported by PREEMPT CRC, a prospective multi-center observational study. To ensure a diverse enrollment, Freenome partnered with several sites, including IHS, in communities with a diverse population. This analysis explores strategies used at IHS Health to effectively enroll minority groups. Methods: Initiated in 2020, PREEMPT CRC study (NCT04369053) enrolled participants aged 45-85 at average CRC risk. Eligible and consenting participants underwent a blood draw and a screening colonoscopy (CS), with the blood sample analyzed by Freenome using the investigational blood test. IHS Health, a research institute in Kissimmee, Florida, utilized a variety of methods to maximize the enrollment of diverse populations reflective of its local communities, such as partnering with local organizations to establish community outreach and employing bilingual staff to translate, educate, answer study questions, with cultural sensitivity. Participants were also able to have blood drawn and undergo CS on the same day due to its proximity to a gastroenterology office. Results: The site of IHS Health enrolled 427 participants in the PREEMPT CRC study, including substantial representation of Hispanic/Latinx (78.7%) which exceeded their proportional representation in the U.S. population. The self-reported race of enrolled participants was predominantly White (71.2%), with a significant proportion of Black or African American (24.1%). The age distribution showed higher enrollment for the 65-74 age group, emphasizing inclusivity for older populations characteristic of the catchment area. Participants exhibited healthy lifestyle behavior with the majority of the population abstaining from tobacco (88.8%), alcohol (84.1%) or drug use (99.5%). Participants were very receptive to the blood test/CS with all undergoing blood draw and 96% CS adherence. Conclusions: The results underscore the success of IHS Health's recruitment methods in addressing health disparity by emphasizing the importance of inclusivity in clinical trials, leading to high enrollment of Hispanic/Latinx, reflective of local demographics. Success of PREEMPT CRC study highlights the need for careful site selection, robust recruitment strategies, and practical accessibility for patients to ensure a comprehensive understanding of medical interventions across diverse populations. Clinical trial information: NCT04369053 .