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Cancer Prevention Clinicogenomics Core

In most academic medical center and cancer center settings, where most robust clinicogenomic registries reside, the genetics of premalignant lesions (i.e. liquid biopsy material from blood) and the natural progression of disease are often not available. In addition, the study of social and environmental factors intertwined with genetics is limited because biospecimens are collected after a cancer diagnosis is made and retrospective analysis of health records is limited to data obtained within the oncology ecosystem. As such, typical registries and biobanks do not currently serve the needs of Cancer Interception and Precision Prevention programs, thus limiting hypothesis generation in that segment of the patient journey. In cancer screening and prevention, it becomes a challenge to study cancer biology without a tumor. Therein lies an opportunity for a thoughtfully designed longitudinal surveillance program in high-risk populations.

General medical practice now has risk-based guidelines for screening for lung cancer, liver cancer, cervical cancer, and breast cancer. Texas A&M has three CPRIT-funded cancer screening programs deployed statewide that, to date, have had limited research infrastructure since funding was limited to clinical service. Our clinicogenomics programs aim to fill these research gaps.

Core Director

Rick Silva, PhD

Director, Texas A&M Clinicogenomics Core

Dr. Silva joined Texas A&M to develop an external-facing collaborations program to augment the clinical and economic impact of the research enterprise at Texas A&M. In his career, he has successfully led over 300 transactions with academic, nonprofit, and commercial organizations in the US, Europe, and Asia, ranging from start-ups to Fortune 500® companies including facilitation of the creation of 60 biomedical startup companies.

Background And Rationale

The Framingham studies provided a robust platform from which to build risk models that leverage biomarkers to prevent cardiovascular disease. These seminal studies have led to marked reductions in mortality from cardiovascular disease over the last 50 years.3 A major challenge to the implementation of chemoprevention strategies is the lack of reliable surrogate biomarkers of disease progression and resolution.4 Using a definitive cancer diagnosis as a direct clinical endpoint renders most randomized controlled chemoprevention trials impractical due in part to a large study size and time requirements. Further, genetic, social and environmental factors are difficult to study in the primary and community health settings. In most academic medical center and cancer center settings, where most robust clinicogenomic registries reside, the genetics of premalignant lesions and the natural progression of disease are often not available. In addition, the study of social and environmental factors intertwined with genetics is limited because biospecimens are
collected after a cancer diagnosis is made and retrospective analysis of health records is limited to data obtained within the oncology ecosystem. As such, typical registries and biobanks do not currently serve the needs of Cancer Interception and Precision Prevention programs, thus limiting hypothesis generation. We posit that a more complete understanding of cancer development, and the validation of strategies that prevent cancer in at-risk populations would be aided by use of the Framingham approach that takes advantage of digital tools available today to contextualize social and economic disparities. Trust, patient agency, and data governance are currently major impediments to collection and curation of medical records and patient reported outcomes. We are implementing the Provenance Platform in support of our IPGx Registry to digitize governance and address these impediments to longitudinal registry development.

Data management

Data management for Texas Clinicogenomics is still in development. An RFP is ongoing for a data governance platform using blockchain legers will be integrated with and used to manage our research data warehouse and digitally automate de-identification and contract workflows to the extent practical for our enterprise.

Health economic outcomes research is a key tenet of Texas Clinicogenomics research portfolio. Our team has experience in both the abstraction of healthcare
utilization data from an EMR and claims matching from population scale claims databases. Our programmatic philosophy strives to augment implementation science by quantitating the utility of genomic and diagnostic interventions across time; building a rigorous real world data set that can advance clinical trial design, regulatory science, and accelerate policy development for precision medicine.

Cancer Prevention Clinicogenomic Registry (CPCR) Core

Documentation of the genetic, environmental, and lifestyle, dimensions is crucial to validation and implementation of cancer prevention and treatment strategies. This is often a critical unmet need at academic health centers which limits the ability of cancer investigators to access biospecimens and complete in silico investigations across time, geography, and healthcare organizations along the patient journey
(especially before a cancer diagnosis). The service was modeled after the Interprofessional Pharmacogenomics Clinic (IPGx) Registry launched to study pharmaco-genomic interventions in the Health Hub and Family Medicine clinics of Texas A&M Health. 4, 5

Biorepositories

1) Recruitment

IRB approved materials will used to recruit and get an initial broad research

2) Subject engagement and intake

Intakes and baseline data (i.e. EQ-5D-5L at enrollment) are completed with assistance from a clinical research nurse in the Family Medicine Center in parallel with other engagement activities as part of the CPRIT Cancer Screening Programs or patient receiving routine medical care for at-risk patients not participating in cancer screening programs.

3) Biobanking (Table 4)

Specimens will be collected at the Health Hub in Bryan TX transported to Texas A&M Main Campus for processing and short term storage until batch transfer to long term storage at IBT in Houston.

4) Longitudinal engagement (figure 2)

The Texas A&M Provenance patient centric data governance for sharing of EMR data longitudinally.

The Texas A&M Health Center of Excellence in Cancer Research is funded by a Texas Regional Excellence in Cancer (TREC) award from the Cancer Prevention and Research Institute of Texas (CPRIT).