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Principal Investigator: Jeffrey Kuang Zou Lee
Organization: KAISER FOUNDATION RESEARCH INSTITUTE
Fiscal Year: 2024
Award: $858,270
Funding agency: National Cancer Institute
Project Summary
Multi-cancer detection (MCD) tests, which evaluate cell-free DNA and other biological components with a single
blood draw, are a new frontier in cancer screening, particularly for cancers with no effective screening methods.
Despite commercial availability, little is known about their feasibility, acceptability, and effectiveness across
diverse settings and populations. To address this evidence gap, the National Cancer Institute (NCI) is creating
the Cancer Screening Research Network (CSRN) to conduct rigorous, multicenter cancer screening studies. In
response to RFA-CA-23-020, we propose a CSRN ACCrual, Enrollment, and Screening Site (ACCESS) Hub
that will recruit participants for the initial Vanguard study from Kaiser Permanente (KP) across 21
sociodemographically diverse medical centers in urban, suburban, and semi-rural areas of California that include
~1.45 million adults ages 45-70 years and that can efficiently expand, for follow-up CSRN studies, to 36 medical
centers with ~3 million screening-eligible adults. Our underlying population for the Vanguard study includes large
numbers of Asian or Pacific Islander (311,959), Black (100,910), and Hispanic (285,287) adults covered by
Medicare, Medicaid, and commercial insurance, allowing for oversampling and inclusion of underrepresented
groups. Efficiently linked by administrative and clinical data systems within an integrated health care system, the
KP ACCESS Hub is well-suited to achieve the CSRN’s goals. Our setting provides comprehensive primary and
specialty care with continuous longitudinal tracking of healthcare utilization, including standard of care cancer
screening; has low loss to follow-up due to health plan disenrollment; and captures complete real-time
information on patient encounters, referrals, diagnoses, procedures, test results, treatments, and outcomes in
extensive electronic health record data systems, including laboratory, pathology, radiology, and cancer registry
databases. The KP ACCESS Hub will be led by a multidisciplinary team embedded within KP clinical operations
and research structures. The team has decades of clinical, scientific, and implementation expertise in cancer
screening and proven experience with recruiting participants for large-volume trials, data management, and
specimen collection, including the use of oversampling and other strategies for optimizing participant diversity
and engagement. Drawing on these collective strengths, our specific aims are to: (1) Recruit, enroll, retain, and
follow a sociodemographically diverse sample of 2,400 asymptomatic, average-risk adults ages 45-70 years,
including understanding barriers to participation for underrepresented groups; (2) Develop and assess processes
to effectively communicate MCD test results to participants and providers; (3) Identify and evaluate diagnostic
pathways following a positive MCD test for timely follow-up care; and (4) Collect and transfer high-quality data
and specimens from study recruitment through closeout for all needed endpoints. In close collaboration with the
Coordinating and Communication Center, Statistics and Data Management Center, other ACCESS Hubs, and
the NCI, the KP ACCESS Hub can inform the evaluation of MCD tests across diverse populations.
Terms: <21+ years old><Accounting><Active Follow-up><Address><Adherence><Adult><Adult Human><Advanced Cancer><Advanced Malignant Neoplasm><Age><Anxiety><Asian><Biological><Black><Black race><Blood><Blood Reticuloendothelial System><Breast><California><Cancer Burden><Cancer Detection><Cancers><Caring><Cause of Death><Cervix><Cervix Uteri><Cessation of life><Clinical><Clinical Data><Collaborations><Colon Cancer><Colon Carcinoma><Communication><Data><Data Bases><Data Coordinating Center><Data Coordination Center><Data Systems><Databases><Death><Diagnosis><Diagnostic><Early Diagnosis><Early treatment><Effectiveness><Electronic Health Record><Eligibility><Eligibility Determination><Enrollment><Ensure><Evaluation><Funding><General Radiology><Goals><Guidelines><Health Care Systems><Health Care Utilization><Health Insurance for Aged and Disabled, Title 18><Health Insurance for Disabled Title 18><Healthcare Systems><Hispanic><IT Systems><Individual><Information Systems><Information Technology Systems><Insurance><Integrated Health Care Systems><Investigators><Knowledge><Laboratories><Leadership><Link><Lung><Lung Respiratory System><Malignant Neoplasms><Malignant Tumor><Medicaid><Medical center><Medicare><Methods><Monitor><Morbidity><Morbidity - disease rate><NCI Organization><National Cancer Burden><National Cancer Institute><Outcome><Pacific Islander><Participant><Pathology><Pathway interactions><Patient Recruitments><Patients><Population><Population Heterogeneity><Position><Positioning Attribute><Positive Test Result><Prevention><Procedures><Process Assessment><Protocol Screening><Provider><Radiology><Radiology Specialty><Recommendation><Research><Research Personnel><Research Specimen><Researchers><Risk><Rural Population><Rural group><Rural people><Sampling><Screening for cancer><Site><Specialty><Specimen><Structure><T-Stage><Test Result><Testing><Time><Title 18><Tumor stage><Underrepresented Groups><Underrepresented Populations><United States><Uterine Cervix><active followup><adulthood><ages><biologic><cancer in the colon><cancer registry><cancer type><cell free DNA><cell free circulating DNA><data acquisition><data acquisitions><data base><data management><data management and coordinating center><data management center><detection test><detection tests><diverse populations><early cancer detection><early detection><early screening><early therapy><effective therapy><effective treatment><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><enroll><experience><follow up><follow-up><followed up><followup><frontier><health care service use><health care service utilization><health care settings><health insurance for disabled><health plan><health plans><healthcare service use><healthcare service utilization><healthcare settings><healthcare utilization><heterogeneous population><improved><ineffective therapies><ineffective treatment><integrated care><integrated health system><integrated healthcare systems><integrated model of care><integrated system of care><malignancy><medical specialties><mortality><multi-ethnic><multidisciplinary><multiethnic><neoplasm registry><neoplasm/cancer><operation><operations><outreach><participant recruitment><pathway><patient centered><patient oriented><population diversity><prevent><preventing><primary care provider><prospective><providers from primary care><providers of primary care><pulmonary><recommended screening><recruit><response><rural area><rural individual><rural location><rural region><sample collection><screening><screening cancer patients><screening guidelines><screening recommendations><screenings><socio-demographics><sociodemographics><specimen collection><standard of care><statistics><suburb><suburban><suburbia><under representation of groups><under represented groups><under represented people><under represented populations><underrepresentation of groups><underrepresented people>