clinical trials |
Ovarian SPORE Core ResourcesThe Ovarian SPORE is comprised of four research projects and three scientific cores designed to consolidate and facilitate expertise required for effective ovarian cancer research. These cores and the projects are overseen by an Administration Core that also manages the Career Development Program and Developmental Research Program. Core 1 – Administration (Lynn Hartmann, M.D. and Scott Kaufmann, M.D., Ph.D.) Core 1Administration Core (Lynn Hartmann, M.D. and Scott Kaufmann, M.D., Ph.D.) The Administration Core underlies, and is totally integrated into, all components of the SPORE, serving as the central hub for administrative and communications support. Led Dr. Hartmann, it facilitates interactions between the SPORE and the following entities: Mayo Clinic Cancer Center (MCCC) and Mayo Clinic as a whole, the National Cancer Institute, other SPOREs at Mayo Clinic, other Ovarian SPORES, and other collaborators outside Mayo. It provides administrative support for the SPORE PI and Co-PI, the SPORE Executive Committee, the Internal Scientific Advisory Committee, and the External Advisory Board. The Core also provides administrative support and fiscal management for the translational research projects and other Cores. It also provides the administrative support for the Developmental Research Program and Career Development Program. Regarding interactions with the other cores, the Administration Core is critical for Biospecimens/Patient Registry, Biostatistics, and Animal Model cores as the final arbiter of any conflicts over prioritization of core use. By monitoring both core usage and project progress, the Administration Core will be poised to efficiently recommend or evaluate proposed changes in core procedures or services. Dr. Hartmann will direct the Administration Core, in close consultation with the SPORE Co-PI/Administration Core Co-Director, and Executive Committee, to maximize the effectiveness of the Ovarian SPORE effort and its clinical-translational impact. Specifically, the Administration Core will:
Core 2Biospecimens and Patient Registry Core (Debra Bell, M.D., and Wilma Lingle, Ph.D.) Mayo Clinic has a strong tradition of biospecimen acquisition for research purposes; indeed, paraffin embedded tissues and histological slides from surgeries performed since 1905 are maintained in the Mayo Tissue Registry. The Biospecimen Accessioning and Processing (BAP) and Tissue and Cell Molecular Analysis (TACMA) Shared Resources of the MCCC have been established to provide the interface between clinical practice and the research arena in a manner that does not adversely impact patient treatment or compromise patient confidentiality. MCCC's BAP and TACMA Shared Resources provide clinically annotated normal and neoplastic human tissues and other specimens for cancer research at Mayo, and are resources of expertise, collaborative support, and service for pathology, immunohistochemistry, laser capture microdissection, tissue microarray preparation, and nucleic acid extraction. These shared resources have developed standard operating procedures for proper handling of biospecimens to maximize consistent collection of high quality specimens and to minimize physical destruction or autolysis due to delays in processing. The Ovarian SPORE Biospecimens/Patient Registry Core is integrated with the BAP and TACMA Shared Resources of the MCCC for ease of administration, to avoid duplication of existing infrastructure, and to take full advantage of existing expertise. Existing MCCC and institutional infrastructure is augmented by this ovarian-specific Core, providing a coordinated, centralized, and dedicated system for identifying and consenting ovarian patients and for procuring and processing biospecimens obtained from these patients to specifically support the Ovarian SPORE program. Dr. Lingle, the Co-director of the Biospecimen/Patient Registry Core, will facilitate this integration as part of her responsibilities as Director of the TACMA and Co-director of the BAP MCCC Shared Resources. The Biospecimens Core works closely with the Biostatistics Core to assure appropriate selection of study-specific sample sets and to administer databases holding inventory, epidemiologic, and clinical data. The Biospecimens Core will support each project by providing annotated biospecimens from ovarian cancer patients as required, along with expertise and assistance in processing the biospecimens per the needs of each project. The Core will also be available to awardees of Career Development and Developmental Research Project awards. Core 3Biostatistics Core (Ann Oberg, Ph.D.) Led by Dr. Oberg – the lead statistician for the Ovarian Research Group within the Women's Cancer Program since 2004 – the Biostatistics Core assures each SPORE investigator access to statistical expertise and the extensive MCCC biostatistical infrastructure that includes collaborative development of study designs, data collection forms and data management systems, analysis plans, state-of-the-art statistical modeling, analysis and interpretation of complex data, abstract and manuscript preparation, and data archiving. This core will provides statistical collaboration and resources for the developmental projects conducted via the Developmental Research Program and Career Development Program of the SPORE. The Biostatistics Core interacts on a daily basis with the Biospecimens/Patient Registry Core by way of the integrated databases that store tissue inventory records, baseline and follow-up clinical data, and epidemiologic data. The Biostatistics Core generates appropriate biospecimens sample sets for each project as required, and is highly involved in project design and analysis for experiments performed in the Animal Models Core. The strengths of the Biostatistics Core lie in its collaborative relationship with each of the SPORE projects, its integration with the Biospecimens/Patient Registry Core, its strong integration with the biostatistical infrastructure at Mayo (including that of the other SPOREs), and the diverse experience of its members. Core 4Animal Models Core (Keith Knutson, Ph.D. and Kah-Whye Peng, Ph.D.) This Core provides technical expertise in establishing, measuring, imaging, and harvesting ovarian tumors and tissues from mice for project 2, project 3, and project 4. Animal models include athymic mice bearing xenografts (standard tumor growth model), immunocompetent mice bearing syngeneic ID8 murine ovarian carcinoma cells, and transgenic colonies as described in the Projects. Individual projects bear the costs of tumor imaging such as luciferase for bioluminescent imaging and radioisotopes for X-SPECT imaging; however, the Core provides the mice, technical support, and standard supplies such as anesthetics. This Core provides essential services and technical expertise to the projects, eliminating the need for individual laboratories to establish parallel methodologies, thereby saving both time and money. The Animal Models Core relies upon the Biostatistics Core to ensure that animal experiments are performed using the smallest number of animals possible while still retaining sufficient statistical power to answer the research question. The purpose of the Ovarian SPORE is to stimulate and facilitate rigorous translational research in ovarian cancer – work that will take new basic and population science discoveries and convert them to improved interventions for women with ovarian cancer. Three of the four projects in this SPORE rely heavily on the Animal Models Core for the evaluation of novel interventions and for refining experimental approaches and delivery regimens in ovarian cancer-bearing mice. To ensure that all the animal experimentation can be performed in an expert and efficient manner, the Animal Core will serve as a central resource and, in collaboration with the laboratory personnel from each project, will perform all the animal experimentation described in the projects. Specifically the Animal Core will:
The Animal Model adds value to the Ovarian SPORE by providing consistency in animal modeling, expertise in animal models, optimal interaction across projects, and efficiency in animal use and care. These services are also available to awardees of the Career Development and Developmental Research programs. |
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