CORE--CLINICAL RESEARCH FACILITY

临床研究核心的目标是为孢子研究人员提供高质量的生物显微镜以及来自同意的胶质瘤患者的患者数据，并为未来的研究提供这些资源。提供的服务包括：1)协调包括血液、咽拭子、尿液和脑脊液在内的生物标本的收集、处理、存储、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，将所有新诊断的未参加介入临床试验的胶质瘤患者录入神经肿瘤学数据库；B：登记对照 他们的年龄、性别和种族与项目4的病例相匹配；3)提供参加干预性临床试验的患者的特定方案临床数据；以及4)协调和监督涉及人类受试者的监管问题的遵从性。该核心还将作为与梅奥诊所癌症中心共享资源的接口，包括 生物检疫采集和处理共享资源、临床研究办公室以及方案审查和监测系统。此外，这一核心将与孢子应用的其他核心互动，包括作为执行委员会成员参与的行政核心，通过共同开发数据输入表和临床数据的质量保证与生物统计核心互动，并通过分担生物检验审查和利用的责任与病理学核心互动。 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和项目4的所有目标以及一个发展项目的基本生物监测和数据提供支助。核心用途将包括协助招募患者参加研究，确保资格，知情同意，安排适当的方案测试和后续行动，每年从大约200名患者和125名对照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制定的梅奥临床癌症中心政策输入临床试验数据信息，以及根据梅奥临床癌症中心的政策遵守人体保护。 最后，这一核心将与其他脑瘤孢子受赠者、癌症中心和合作小组的临床研究部门对接，以促进由国家脑瘤研究努力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.