Brain SPORE Core Resources

The Mayo Clinic Cancer Center SPORE in Brain Cancer comprises four Mayo investigator-initiated research projects, and four scientific core resources constructed around a theme of adult gliomas and consolidated by an Administrative Core. The SPORE also contains Career Development and Developmental Research Programs.

Core 1 - Administrative Core (Brian O’Neill, M.D. and Robert Jenkins, M.D., Ph.D.)
Core 2 - Biostatistics Core (Karla Ballman, Ph.D.)
Core 3 - Pathology Core (Caterina Giannini, M.D., Ph.D.)
Core 4 - Xenograft Core (Jann N. Sarkaria, M.D.)
Core 5 - Clinical Research Core (Jan Buckner, M.D.)

Core 1
Administrative Core (Brian O’Neill, M.D. and Robert Jenkins, M.D., Ph.D.)

The Administrative Core supports the operational structure of this SPORE. It provides coordination of the research projects, scientific cores, and developmental programs (Developmental Research Program, Career Development Program) of the SPORE. It serves to enhance communication between SPORE investigators and facilitate all SPORE operations and interactions. The Administrative Core is responsible for coordinating the SPORE Executive Committee and the Advisory Council. Dr. O’Neill is Director of the Administrative Core, and Dr. Jenkins serves as Co-Director.

The Administrative Core supports SPORE activities by:

• Providing leadership, organizational support, and financial management for SPORE investigators
• Coordinating monthly scientific meetings of SPORE investigators, and the ongoing scientific review of SPORE research projects and cores
• Reviewing progress of the SPORE full and developmental projects
• Providing for information transfer to the scientific community via professional and public means
• Providing the structure for nurturing collaborations to facilitate and expand glioma research
• Acting as liaison with leadership of the other Brain SPOREs and the NCI SPORE Program

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Core 2
Biostatistics Core (Karla Ballman, Ph.D.)

The Biostatistics Core is in itself multifaceted, combining the talents and experience of biostatisticians familiar with basic science experiments, population science studies, and cancer clinical trials. This Core interacts with all projects, bringing the insight and rigor of statistical analysts to achieve the most meaningful results. It provides statistical collaboration and/or data management for each of the SPORE projects, developmental projects, and cores. Each project in this application reflects input from members of the Biostatistics Core on study design and analysis plans.

Statistical collaboration and analysis involve many different fields, including epidemiologic studies, basic sciences, and clinical trials. These studies are conducted across different platforms with different data management needs, from in vitro experiments to in vivo murine models to phase I/II cancer clinical trials. The Biostatistics Core provides each investigator access to statistical expertise that includes collaborative development of study designs, data collection tools, analysis plans, state of the art statistical modeling, analysis and interpretation of complex data, data management resources, and abstract and manuscript preparation.

The Core also provides statistical collaboration and resources for the developmental projects as well as for pilot projects initiated through the career development component of this grant. In this sense, the Biostatistics Core not only collaborates on and supports the projects presented in this grant application but also will serve as a resource for future investigators interested in participating through this SPORE. In addition to providing statistical collaboration on current and future projects, the Biostatistics Core works closely with the Clinical Research Core and the Xenograft Core to develop data quality control processes and to assist with the development of new databases or to add database functionality. The Biostatistics Core also develops and helps manage project-specific databases as well as to perform necessary data quality control checks.

The strengths of the Biostatistics Core are its collaboration with each of the projects, its close integration with the Clinical Research Core and Xenograft Core and the diverse experience of its members. The Biostatistics Core builds upon innovative and time-tested procedures and systems developed by one of the largest statistical groups in the country whose members have collaborated on more than 8,000 clinical and basic science research studies since 1932.

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Core 3
Pathology Core (Caterina Giannini, M.D., Ph.D.)

The goal of the Pathology Core of the Mayo Clinic Cancer Center SPORE in Brain Cancer is to procure tissue and specimens from nearly every newly diagnosed or relapsed glioma patient seen at Mayo Clinic and from all patients entered onto SPORE protocols.

This Core provides a coordinated and centralized resource dedicated to procurement and processing of tissues obtained from patients with gliomas. The Pathology Core coordinates acquisition of both normal and neoplastic brain tissues for translational research and ensures appropriate diagnosis and quality of tissue. A portion of normal and tumoral brain tissue from each patient is obtained fresh, processed for culture/xenograft and/or stored frozen to provide investigators with DNA and RNA. The remainder of the tissue is available in paraffin blocks stored at the Mayo Clinic Tissue Registry. Oversight is provided by the Administrative Core and its Executive Committee.

The Pathology Core also serves as a resource of expertise, collaborative effort and service for the pathology needs of the individual projects. The Core interfaces and is electronically integrated with the Neuro-Oncology Database and the Biostatistics Core to provide investigators with clinically annotated tissues. Collection, banking, and use of tissue is performed with appropriate patient consent and institutional approval. The Pathology Core also interacts and collaborates with other Brain Tumor SPOREs to promote resource sharing, and integrate scientific projects of mutual interest.

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Core 4
Xenograft Core (Jann N. Sarkaria, M.D.)

The Xenograft Core serves a crucial need in the provision of mouse models that recapitulate the malignant phenotype of human glioblastomas. The current Mayo Xenograft mouse model is arguably the best model for developmental therapeutics currently available to brain cancer investigators.

Through the development and maintenance of several serially transplantable glioblastoma multiforme tumor lines, each of which has been or will be characterized for glioblastoma multiforme signature lesions, the Xenograft Core provides to SPORE investigators robust animal models that recapitulate the invasiveness seen in the human phenotype. The serially passaged xenografts provide a more clinically relevant model than established cell lines grown as xenografts. This determination has many implications for neuro-oncology research, but is likely to be of greatest importance to the testing of experimental therapeutics. It is our contention that results from testing anti-tumor therapeutics with serially-transplanted glioblastoma multiforme xenografts will show improved consistency with clinical trial results in humans.

Specifically, the Xenograft Core conducts the following activities in support of the Mayo Brain SPORE:

• Initiate, passage, and archive xenograft tumors derived from Mayo glioma patients
• Provide detailed molecular characterization of each xenograft upon establishment and monitor for retention of characteristics
• Collect, process, and distribute within and outside Mayo, paraffin-embedded xenograft tumor tissues, serum/plasma, DNA, RNA, and protein
• Coordinate and conduct all in vivo therapeutics testing, including NMR image analysis of intracranial xenografts as needed to assess tumor response to therapy
• Maintain up-to-date records on all xenograft tissues and related biospecimens. All specimens are collected and processed under tight quality control, and distributed to SPORE researchers or banked for future SPORE research projects. The SPORE Pathology Core assures that specimens are properly fixed, stained, and histologically evaluated. All activities will be tracked in the Biostatistics Core using a sophisticated database essential to the SPORE. This database merges the activities at Mayo, and allows integration with clinical and other data collected in research projects

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Core 5
Clinical Research Core (Jan Buckner, M.D.)

The Clinical Research Core coordinates research access on all appropriately consented brain cancer patients and their biospecimens at Mayo. Recruitment is done rapidly (at the time of the initial consultation or at the time of tissue diagnosis), and protocols are established to obtain and distribute blood and tissue specimens to meet needs of the investigators.

The goal of the Clinical Research Core is to provide investigators in the SPORE high quality biospecimens as well as patient data from consented patients with glioma and to make these resources available for future studies.

The services provided are:

• To coordinate the collection, processing, storage, distribution and tracking of biospecimens including blood, throat swabs, urine and cerebrospinal fluid
• To extract clinical data from patient records and collect epidemiologic research information, with entry into the neuro-oncology database for all newly-diagnosed glioma patients not on interventional clinical trials
• To enroll controls who are age, gender, and race-matched to cases for Project 4
• To provide protocol-specific clinical data from patients enrolled in interventional clinical trials
• To provide coordination and oversight of compliance with regulatory issues involving human subjects

The Clinical Research Core will also serve as the interface with Mayo Clinic Cancer Center’s shared resources including the Biospecimens Acquisition and Processing shared resource, the Clinical and Translational Science Activities (CTSA) office, and the Protocol Review and Monitoring System. In addition, this Core will interact with the other cores of this SPORE application, including the Administrative Core by participating as a member of the Executive Committee, with the Biostatistics Core by joint development of data entry forms and quality assurance of clinical data, and with the Pathology Core by sharing the responsibilities for biospecimens review and utilization.

These essential services provide support for all the projects and one developmental project. Core utilization includes assisting in the recruitment of patients to studies, ensuring eligibility, informed consent, scheduling appropriate protocol tests and follow-up, obtaining clinical data and biospecimens from approximately 200 patients and 125 controls per year, entry of clinical trials data information according to Mayo Clinic Cancer Center policy set forth by the CTSA and Protocol Review and Monitoring System, and compliance with human subjects protection in keeping with the policies of Mayo Clinic Cancer Center.

Finally, this Core will interface with the clinical research components of other Brain Tumor SPORE grantees, cancer centers and cooperative groups to facilitate multi-institutional clinical research arising out of national brain tumor research efforts.