Institute for Population and Precision Health, University of Chicago Chicago, IL
Jennifer Herbert, DNP, FNP-BC, APRN1, Karolina M. Kutnik, MS2, Lilian C.. Lee, PhD2, Chuanbo Xu, PhD3, Lance Baldo, MD4, Aasma Shaukat, MD5, Theodore R. Levin, MD6, Ahsan Habibul, MBBS7 1Institute for Population and Precision Health, University of Chicago, Chicago, IL; 2Freenome, South San Francisco, CA; 3Freenome, Inc., San Jose, CA; 4Freenome, Inc., South San Francisco, CA; 5NYU Langone Health, New York, NY; 6Kaiser Permanente, Oakland, CA; 7University of Chicago, Chicago, IL
Introduction: Clinical trials face ongoing challenges when it comes to underrepresentation of minority groups, particularly Black and African American (AA) individuals who make up 13.6% of the US population but less than 5% of oncology trial participants despite experiencing higher incidence and mortality of colorectal cancer (CRC). Freenome is developing a blood-based, multiomics test FMBT-CRC, with the aim of providing a convenient and accessible option for CRC screening. Clinical validation of FMBT-CRC is being supported by PREEMPT CRC: a prospective, observational, blinded, multi-center study. To ensure diversity, a partnership was established with the Institute for Population and Precision Health (IPPH) at the University of Chicago (UOC), which also participates in the Precision Medicine Initiative, All of Us Research Program, and Chicago Multiethnic Prevention and Surveillance Study.
Methods: UOC used a range of methods to maximize the recruitment of Black and AA participants in PREEMPT CRC, including: local partnerships with a variety of institutions, utilization of Mobile Research Units that brought phlebotomists to targeted communities, engagement in local home visits, and clinic-based recruitment at the outpatient and satellite sites. The enrollment was compared among racial and social groups, and with the US demographic.
Results: The UOC enrolled 269 participants with average risk for CRC, among which the majority were females (65.1%). The average age of enrollment was 58.8 ± 8. The majority of enrolled participants were Black or AA (68.0%) followed by White participants (24.9%) (Table 1). This proportion is higher than general enrollment in oncology trials and exceeded the proportional representation in the US population (Figure 1). The majority of enrolled patients had private payer insurance (63.2%) and were either married (42.0%) or single (36.1%).
Discussion: The results highlight the success of UOC programs and initiatives that address barriers to healthcare. Deployment of community-specific methods helped contribute to the diversity in PREEMPT CRC, and importantly drove participation that was truly representative of UOC’s local community. Diversity is important in cancer screening studies. Hence, clear commitment and careful planning, which begins by involving clinical sites located in traditionally difficult-to-reach populations and implementing focused approaches that facilitate easier trial participation, are crucial for inclusivity.
Figure: Figure 1. Proportion of Black or African American (AA) enrolled by University of Chicago (UOC) in PREEMPT CRC study in comparison to U.S. population and average participation of those communities in clinical trials for 2020 FDA oncology approvals. Data from *US Census Bureau; ** FDA 2020 Drug Trials Snapshots Summary Report.
Enrolled Participants
count
%
Total enrollment
269
Female
175
65.1%
Male
94
34.9%
Age
58.8 ± 8.3
BMI
31.4 ± 7.3
Race
Black or African American
183
68.0%
White
67
24.9%
Asian
6
2.2%
American Indian or Alaska Native
1
0.4%
Mix
5
1.9%
Other
5
1.9%
Unknown
2
0.7%
Ethnicity
Hispanic or Latino
22
8.2%
Not Hispanic or Latino
239
88.8%
Refuse to answer
3
1.1%
Unknown
4
1.5%
Not Reported
1
0.4%
Insurance Payers
Private Payer Insurance
134
63.2%
Public Payer: Medicaid
50
23.6%
Public Payer: Medicare/Medicare Advantage
64
30.2%
Unknown
21
9.9%
Marital Status
Married
113
42.0%
Single
97
36.1%
Divorced
25
9.3%
Widowed
12
4.5%
Table: Table 1. Baseline Participants’ Demographic and Sociodemographic Information
Disclosures:
Jennifer Herbert: Freenome, Inc – Sub-investigator at a contracted research site for the company. Janssen Vaccines and Prevention B.V. – Research staff at a contracted research site for the company.
Karolina Kutnik: Freenome – Employee.
Lilian Lee: Freenome – Employee.
Chuanbo Xu indicated no relevant financial relationships.
Aasma Shaukat indicated no relevant financial relationships.
Theodore Levin indicated no relevant financial relationships.
Ahsan Habibul indicated no relevant financial relationships.
Jennifer Herbert, DNP, FNP-BC, APRN1, Karolina M. Kutnik, MS2, Lilian C.. Lee, PhD2, Chuanbo Xu, PhD3, Lance Baldo, MD4, Aasma Shaukat, MD5, Theodore R. Levin, MD6, Ahsan Habibul, MBBS7. P0336 - Strategic Approaches for Enhancing Diversity in a Colorectal Cancer Screening Study Among Black and African American Communities, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.
