GI SPORE: Cores (Institutional Funding)
Core A: Administrative Core
Core Director: Evers, B. Mark
The purpose of the Administrative Core is to provide support for the translational research objectives of our SPORE by serving as the organizational hub that connects, optimizes and facilitates collaboration among SPORE investigators within and outside of the University of Kentucky (UK). The Administrative Core is led by B. Mark Evers, MD, SPORE principal investigator, who oversees all SPORE activities. The core’s codirectors, Mark Dignan, PhD, and Stanley M. Lemon, MD, assist Dr. Evers. The Administrative Core also includes an experienced and well-trained team that ensures and coordinates the Specific Aims of the Core, which are: 1) To provide coordination for all scientific and educational activities of the SPORE; 2) To provide centralized and coordinated administrative support for the daily activities involving all components of the SPORE: research projects, cores, developmental programs and career development programs; and 3) To facilitate and coordinate SPORE outreach activities. To facilitate these aims, the Administrative Core organizes and manages: the overall SPORE interactions; administrative/scientific oversight of all research projects, cores and developmental programs; and the activities of the external, internal and patient advocates advisory boards. In addition, the core is responsible for ensuring regulatory compliance for the SPORE’s day-to-day operation and management, including monitoring of expenditures and addressing general grant and data management and policy issues. Administrative staff also oversee and facilitate the SPORE’s outreach activities.
Core B: Biospecimen Procurement and Analysis Core (Biospecimen Core)
Core Codirectors: PULLIAM, Joseph, CIBULL, Michael and LEE, Eun
The Biospecimen Procurement and Analysis Core (Biospecimen Core) procures and distributes biospecimens and provides expertise and support for the investigators of the University of Kentucky (UK) Gl SPORE to perform specialized histopathologic, immunohistochemical and molecular analyses. The use of both neoplastic and non-neoplastic human and animal tissues is a key component of translational, population-based and basic science research. The goals of the Biospecimen Core are to provide formalin-fixed paraffin-embedded (FFPE) tissues, frozen tissue, blood, urine and toenail specimens, and histopathological and immunohistochemistry expertise for the GI translational studies related to the aims of the research projects comprising this SPORE proposal. To meet these goals, the following Specific Aims are proposed: 1) to provide quality-controlled human tissue biospecimens necessary for all GI cancer translational research studies, including both frozen and FFPE tissues, annotated with clinical follow-up and outcomes; 2) to provide expert pathological review for all clinical specimens utilized in the SPORE projects and to provide specific histopathological technical services as necessary for analysis of all clinical and animal tissues; and 3) to coordinate and facilitate acquisition and quality control of tissue samples from the Markey Cancer Center (MCC) affiliate hospitals required for the population-based studies in Appalachian Kentucky. The Biospecimen Core will leverage the existing resources within the MCC, the UK Department of Pathology and Laboratory Medicine, the MCC Clinical Research Coordinating Center and the Kentucky Cancer Registry, thus assuring that this core will benefit from previous efforts and techniques and that funds will be used efficiently without reproducing existing facilities.
Core C: Biostatistics and Informatics Core (BIC)
Core Director: WEISS, Heidi L.
The objective of the Biostatistics and Informatics Core (BIC) is to provide a comprehensive and centralized support that integrates the biostatistical activities of this GI SPORE. To address this overall goal, the Specific Aims of the core are to:
Aim 1. Coordinate and manage the statistical activities to ensure that investigators have ready access to biostatistical consultation that will facilitate a collaborative environment within the SPORE.
Aim 2. Provide investigators with biostatistical expertise in study planning, design, and state-of-the-art statistical analysis of the translational projects, which will encompass laboratory, preclinical experiments, biomarker and bioinformatics studies in clinical biospecimens, clinical trials and population studies.
Aim 3. Provide comprehensive support during study conduct to include interim analysis, generation of progress reports, data management and quality control activities.
Aim 4. Provide investigators with informatics expertise specifically to maintain and enhance design of an integrated database information management system, facilitate data sharing and ensure data security.
This GI SPORE proposes laboratory and murine experiments, clinical biospecimen and bioinformatics translational studies, early phase clinical trials to assess safety and biological modulation of targeted therapies and population-based cancer interventions. The BIC will play a key role in provision of scientific and statistical input and utilize sound experimental principles in study planning and development, maintain and enhance an information management system, developed during the pilot funding of this SPORE, to promote widespread and secure data sharing across the SPORE components, and facilitate provision of timely and high-quality statistical analysis and data interpretation. The BIC of this SPORE application will draw biostatistical and informatics expertise from existing members of the Markey Cancer Center’s Biostatistics and Informatics Shared Resource Facilities, respectively.