Clinical Research Core

临床研究核心

• 批准号: 8567084
• 负责人: JAN C BUCKNER
• 金额: $ 14.83万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8567084
• 关键词: Adverse event; Animals; Award; Biostatistics Core; Blood; Brain Neoplasms; Cancer Center; Center for Translational Science Activities; Clinic; Clinical Data; Clinical Research; Clinical Trials; Collection; Consent; Consultations; Data; Databases; Development; Eligibility Determination; Enrollment; Ensure; Future; Glioma; Goals; Human; Informed Consent; Joints; Malignant neoplasm of brain; Mayo Clinic Cancer Center; Monitor; Mus; Normal tissue morphology; Pathology; Patient Participation; Patient Recruitments; Patients; Policies; Process; Protocols documentation; Quality Control; Records; Recruitment Activity; Reporting; Research; Research Personnel; Resource Sharing; Resources; Saliva; Schedule; Services; System; Testing; Therapeutic Clinical Trial; Tissue Procurements; Tumor Tissue; Urine; Visit; Xenograft procedure; career development; follow-up; human subject; human subject protection; member; neuro-oncology; programs; quality assurance

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.

临床研究核心的目标是识别、招募和同意胶质瘤患者提供 研究人员在孢子高质量的生物标本和由此得出的人口统计学和临床数据，并以 为将来的研究提供这些资源。具体目标是： 具体目标1：识别、招募并同意所有胶质瘤患者参加观察人类 研究，并将脑肿瘤组织用于核心和项目概述的多种目的；获得 患者记录中的人口学和临床数据，并将数据输入梅奥诊所神经肿瘤学 数据库； 具体目标2：协调包括血液、唾液和尿液在内的正常组织生物样本的收集； 具体目标3：筛选、同意并招募所有参与治疗临床试验的患者，提供 对特定方案的治疗进行质量控制，收集和输入特定方案的临床数据 前瞻性地报告不良事件，并为患者安排所有的就诊、测试、会诊和治疗 参加治疗性临床试验； 具体目标4：在制定和实施观察性和治疗性原则方面提供咨询 临床试验，包括监督对涉及人体受试者的监管问题的遵守情况 这一核心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、临床研究办公室和议定书 审查和监测系统，以及梅奥支持的机构临床研究股 临床转化科学活动中心(CTSA)奖。此外，该核心还将与 此孢子应用程序的其他核心，包括作为 执行委员会，与动物核心，通过获得患者同意使用脑瘤组织用于 以生物统计学为核心的小鼠异种移植，通过联合开发数据录入表格和质量保证 临床数据，并通过分担责任与病理和组织采购核心 同意和收集生物标本。 这些基本服务为项目1、具体目标3、项目2、具体目标4、项目4、 具体目标1B、2A和2B；动物、生物检疫和组织采购，生物统计核心；以及 职业发展和发展研究计划。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 以及随访，从登记参加临床试验的患者那里获得临床数据和生物标本，进入临床试验 根据临床研究办公室制定的梅奥临床癌症中心政策提供的试验数据信息 和议定书审查和监测系统，并遵守对人类主体的保护 梅奥诊所癌症中心的政策。 最后，这个核心将与其他脑瘤孢子受赠者的临床研究部分对接， 癌症中心和多中心小组促进国家多机构临床研究 脑瘤研究的努力。