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: 1) to coordinate the collection, processing, storage, distribution and tracking of biospecimens including blood, throat swabs, urine and cerebrospinal fluid; 2) A: 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 and B: to enroll controls who are age- gender- and race-matched to cases for Project 4; 3) to provide protocol-specific clinical data from patients enrolled in interventional clinical trials; and 4) to provide coordination and oversight of compliance with regulatory issues involving human subjects. This 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 Research 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 specific aim 1 of project 1, specific aim 4 for project 2, essential biospecimens and data for all of the aims in projects 3 and 4, and one developmental project. 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 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 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 cooperative groups to facilitate multi-institutional clinical research arising out of national brain tumor research efforts.
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