Clinical Research Core

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The goal of the Clinical Research Core is identify, recruit, and consent patients with glioma to provide investigators in the SPORE high quality biospecimens and corollary demographic and clinical data, and to make these resources available for future studies. The specific aims are: Specific Aim 1: To identify, recruit, and consent all glioma patients for participation in observational human studies, and for use of brain tumor tissue for multiple purposes outlined by the Cores and Projects; to obtain demographic and clinical data from patient records and enter the data into the Mayo Clinic Neuro-Oncology Database; Specific Aim 2: To coordinate the collection of normal tissue biospecimens including blood, saliva, and urine; Specific Aim 3: To screen, consent, and enroll all patients for participation in therapeutic clinical trials, provide quality control for administration of protocol-specific therapy, collect and enter protocol-specific clinical data prospectively, report adverse events, and schedule all visits, tests, consultations, and therapies for patients enrolled in therapeutic clinical trials; Specific Aim 4: To provide consultation in development and implementation of observational and therapeutic clinical trials, including oversight of compliance with regulatory issues involving human subjects This core will serve as the interface with Mayo Clinic Cancer Center's shared resources including the Biospecimens Acquisition and Processing shared resource, the Clinical Research Office, and the Protocol Review and Monitoring System, as well as the institutional Clinical Research Unit supported by the Mayo Clinic Center for Translational Science Activities (CTSA) award. 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 Animal Core by obtaining patient consent for use of brain tumor tissue for mouse xenografts, with the Biostatistics Core by joint development of data entry forms and quality assurance of clinical data, and with the Pathology and Tissue Procurement Core by sharing the responsibilities for consent for and collection of biospecimens. These essential services provide support for Project 1, specific aim 3; Project 2, specific aim 4; Project 4, specific aims 1B, 2A and 2B; the Animal, Biospecimen and Tissue Procurement, the Biostatistics Cores; and the Career Development and Developmental Research Programs. Core utilization will include 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 patients enrolled in clinical trials, entry of clinical trials data information according to Mayo Clinic Cancer Center policy set forth by the Clinical Research Office and Protocol Review and Monitoring System, and compliance with human subjects protection in keeping with the policies of the Mayo Clinic Cancer Center. Finally, this core will interface with the clinical research components of other Brain Tumor SPORE grantees, cancer centers and multi-center groups to facilitate multi-Institutional clinical research arising out of national brain tumor research efforts.