Biorepository, Pathology, and Immune Monitoring Core

摘要-生物储库、病理学和免疫监测核心（核心3） 生物储存库、病理学和免疫监测核心（核心3）将作为关键资源， 这三个项目和发展计划，这个孢子在脑癌，提供全面的 生物储存库，完整的表型和基因型组织病理学评估，以及最先进的 免疫监测这一资源将由一个高度成就的研究科学家团队提供， 我有几十年的经验，这些平台与以前和现在的癌症 免疫治疗试验我们的生物库资源已经积累了超过33，000个冷冻肿瘤块，包括 超过21，000对中枢神经系统肿瘤样本，与匹配的血液样本一起储存在-170 ℃下 超过2,687名患者。工作人员接受良好实验室规范（GLP）培训，生物储存库 由美国病理学家学院认证。样本与杜克医院病理学报告相关联 包括诊断、增殖、表型和基因型数据的概况， 获得良好表征的肿瘤组织。这个核心在人类免疫分析方面也有着广泛的历史 在杜克使用高度标准化和验证的检测方法，从而提供了广泛的最先进的 技术平台，以全面询问免疫治疗的免疫反应。流动 基于细胞计数的表型和功能性免疫分析平台代表了这方面的一个特殊优势。 根据过去和正在进行的广泛应用以及对这些工具的改进， 疫苗和癌症免疫治疗试验和能力测试工作的背景。此外，所有免疫 将根据药物临床试验质量管理规范对SPORE相关临床试验进行监查 （GCLP）。具体目标是：1）提供血液和组织分配和跟踪服务， 组织诊断、免疫组化（IHC）和生物库支持项目的临床和相关 问题研究2)为参加项目的患者提供符合GCLP的全面免疫监测， 使用标准化和经验证的最先进的基于流式细胞术的免疫分析的临床研究 平台该核心还将继续创新，包括将创新方法转化为 开发用于分析脑肿瘤异质性和免疫反应， 预后和治疗反应性临床试验。此外，Inter-SPORE 免疫监测联盟将继续分享新免疫分析的开发和验证 平台，同时还试图标准化标本采集，制备，运输和 根据统一的标准操作程序（SOP）进行评估。

ABSTRACT – Biorepository, Pathology, and Immune Monitoring Core (Core 3) The Biorepository, Pathology, and Immune Monitoring Core (Core 3) will serve as a critical resource for the three projects and developmental programs of this SPORE in Brain Cancer by providing comprehensive biorepository banking, complete phenotypic and genotypic histopathologic assessment, and state-of-the-art immune monitoring. This resource will be provided by a team of highly accomplished research scientists who have decades of experience with these platforms in conjunction with previous and current cancer immunotherapy trials. Our Biorepository resource has accumulated over 33,000 frozen tumor blocks, including over 21,000 paired central nervous system tumor samples, in -170oC storage with matched blood samples from over 2,687 patients. The staff are trained in Good Laboratory Practices (GLP) and the Biorepository is certified by the College of American Pathologists. Samples are linked with Duke Hospital Pathology reports that include a profile of diagnostic, proliferative, phenotypic, and genotypic data in order that researchers have access to well characterized tumor tissues. This Core also has an extensive history of human immune profiling using highly standardized and validated assays at Duke, thus providing a broad repertoire of state-of-the-art technology platforms to comprehensively interrogate immune responses to immunotherapy. The flow cytometry-based phenotypic and functional immune profiling platforms represent a particular strength in this proposal, based on the extensive past and ongoing applications as well as refinements of these tools in the context of vaccine and cancer immunotherapy trials and proficiency testing efforts. Additionally, all immune monitoring of SPORE-associated clinical trials will be performed according to Good Clinical Laboratory Practices (GCLP). The specific aims are 1) To provide blood and tissue distribution and tracking services, tissue diagnosis, immunohistochemical (IHC) and biobanking support to the Projects' clinical and correlative studies. 2) To provide GCLP-compliant, comprehensive Immune Monitoring of patients enrolled in the Projects' clinical studies using standardized and validated state-of-the-art flow cytometry-based immune profiling platforms. This Core will also continue to innovate, including by translating innovative methodologies developed to analyze brain tumoral heterogeneity and immune responses in this Core into diagnostic, prognostic, and therapeutic responsiveness clinical tests for the bedside. In addition the Inter-SPORE consortium for immune monitoring will continue to share development and validation of new immune profiling platforms while also attempting to standardize all aspects of specimen acquisition, preparation, transport, and evaluation according to a uniform set of Standard Operating Procedures (SOPs).