CORE--CLINICAL RESEARCH FACILITY

核心——临床研究设施

• 批准号: 6844512
• 负责人: JAN C BUCKNER
• 金额: $ 17.9万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-10-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6844512
• 关键词: biomedical facility; cancer information system; clinical research; glioma; human subject; tissue resource /registry

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.

临床研究核心的目标是为研究人员提供 SPORE 高质量生物样本以及来自同意的神经胶质瘤患者的患者数据，并使这些资源可用于未来的研究。提供的服务有： 1）协调生物样本（包括血液、咽拭子、尿液和脑脊液）的收集、处理、储存、分发和追踪； 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，将所有未参与介入临床试验的新诊断胶质瘤患者输入神经肿瘤数据库；B：招募对照 与项目 4 的案例年龄、性别和种族相匹配的人； 3) 提供参与介入临床试验的患者的特定方案临床数据； 4) 协调和监督涉及人类受试者的监管问题的遵守情况。该核心还将作为梅奥诊所癌症中心共享资源的接口，包括 生物样本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，该核心将与该 SPORE 应用程序的其他核心进行交互，包括作为执行委员会成员参与的管理核心、通过联合开发数据输入表格和临床数据质量保证与生物统计核心交互、以及通过分担生物样本审查和利用的责任与病理学核心交互。 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 中所有目标的基本生物样本和数据以及一个开发项目提供支持。核心利用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随访、每年从约 200 名患者和 125 名对照者那里获取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诊所癌症中心政策输入临床试验数据信息，以及遵守与梅奥诊所政策一致的人体受试者保护 癌症中心。 最后，该核心将与其他脑肿瘤 SPORE 受资助者、癌症中心和合作团体的临床研究部分相结合，以促进国家脑肿瘤研究工作中产生的多机构临床研究。