CORE--CLINICAL RESEARCH FACILITY

临床研究核心的目标是为SPORE的研究者提供高质量的生物标本以及来自同意的胶质瘤患者的患者数据，并使这些资源可用于未来的研究。所提供的服务包括：1）协调生物标本（包括血液、咽拭子、尿液和脑脊液）的采集、处理、储存、分发和跟踪; 2）A：从患者记录中提取临床数据，并收集流行病学研究信息，将所有未参与干预性临床试验的新诊断胶质瘤患者输入神经肿瘤学数据库; B：招募对照组 与项目4病例的年龄、性别和种族匹配; 3）提供参与干预性临床试验的患者的方案特异性临床数据; 4）协调和监督涉及人类受试者的监管问题的依从性。该核心还将作为与马约诊所癌症中心共享资源的接口，包括 生物标本采集和处理共享资源、临床研究办公室和方案审查和监测系统。此外，该核心将与该SPORE应用程序的其他核心进行互动，包括作为执行委员会成员参与的行政核心，通过联合开发数据录入表和临床数据质量保证与生物统计核心进行互动，以及通过分担生物标本审查和利用的责任与病理学核心进行互动。 这些基本服务为项目1的具体目标1、项目2的具体目标4、项目3和4的所有目标的基本生物标本和数据以及一个发展项目提供支助。核心利用将包括协助招募患者参加研究，确保合格性、知情同意、安排适当的方案检查和随访，每年从约200例患者和125例对照患者中获得临床数据和生物样本，根据临床研究办公室和方案审查和监测系统规定的马约诊所癌症中心政策输入临床试验数据信息，并遵守与马约诊所癌症中心政策一致的人类受试者保护。 最后，该核心将与其他脑肿瘤SPORE受赠者，癌症中心和合作团体的临床研究组成部分对接，以促进国家脑肿瘤研究工作产生的多机构临床研究。

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.