Enrollment strategies to promote inclusion in a colorectal cancer screening study.
Authors: Sam Moskowitz, Zhen Meng, Lilian C. Lee, Yontao Lu, Chuanbo Xu, Lance Baldo, Aasma Shaukat, Theodore R. Levin
Journal: Journal of Clinical Oncology (2024)

e13530 Background: Colorectal cancer (CRC) is the second deadliest cancer in the U.S. and while rates vary among racial/ethnic groups, the Black community is disproportionately impacted with the highest incidence and mortality rates. Notably, CRC rates have also been rising among younger individuals aged 45 to 49. Recruitment of diverse and underrepresented groups, such as the populations described above, is increasingly important to enhance generalizability and real world performance in clinical studies. Freenome is developing a blood-based test (MyTectCRC) with the aim of providing a convenient and accessible option for CRC screening. Clinical validation of MyTectCRC test will be supported by PREEMPT CRC, a prospective, observational, multi-center study. The aim of this analysis is to assess the use of community-based recruitment approaches in a diverse inner-city population in Brooklyn, New York. Methods: PREEMPT CRC enrolled subjects aged 45-85 who were at average risk for CRC. To ensure representation of ethnic groups that have historically been difficult to recruit, the study deliberately engaged sites delivering care in diverse communities. Moskowitz Practice recruited from a patient base consisting largely of city workers in Brooklyn, New York, and deployed several patient-focused, ease-of-access methods such as convenient location for colonoscopy (CS) in an ambulatory surgery center, direct patient education from the physician, direct patient support from attentive and engaged site staff, customizable scheduling and screening reminders, and patient-to-patient referrals. Notably, the same approach was used for all study candidates, regardless of the participant’s ethnic/racial representation. Results: Community-based approaches contributed to strong participation from the site’s community in PREEMPT CRC. Importantly, the participants were representative of the local population with 87.4% of the enrollees identified as Black, a group historically underrepresented in oncology studies. The site also successfully enrolled young participants aged 45 to 50 (20.5%) and more females (58.2%) than males. Participants had relatively healthy lifestyles with 91.4% reporting as non-smokers, and 65% reporting no alcohol use. Study participants were highly compliant with study required procedures such as blood collection (100%) and CS (95%). Conclusions: The community-specific methods utilized by the site helped contribute to the diversity enrollment in PREEMPT CRC while recruiting participants that are representative of the local community. Ensuring diversity in clinical studies is the beginning to promoting equity in CRC screening, diagnosis and treatment. A blood-based test, supported by clinical evidence built on data from a diverse and representative population, may provide a convenient and accessible option for CRC screening and potentially increase the screening rate and reduce the CRC burden. Clinical trial information: NCT04369053 .