Coordinating Center for Canine Immunotherapy Trials and Correlative Studies

犬类试验医疗前免疫治疗网络(辖区)的主要任务是促进在患有癌症的狗身上进行免疫治疗临床试验，并加快识别 成功治疗反应的免疫学相关性。该地区将通过支持由参与U01站点组成的高度协调的临床试验网络来实现这些目标。作为协调中心，该分局将与U01调查人员、指导委员会、NCI比较肿瘤学计划(COP)的代表和外部咨询委员会合作，提供项目管理和研究技术、数据管理、生物统计支持和免疫监测方面的专家服务。 具体来说，我们将建立一个辖区数据协调中心，提供全面的项目监督， 监督所有项目管理和合规活动，协调所有项目的现场管理 单一和大型多地点项目的各个方面。通过该分局，U01研究人员将随时获得研究服务和标准化方案，这些服务和标准化方案将促进临床研究在整个 分局。我们将建立一个区域数据管理系统，收集、存储和共享所有临床和 U01站点之间以及与缔约方会议主任和指导委员会之间的相关数据。我们将开发 实现高效、高度运行的协调网络并制定标准所需的基础设施 可应用于所有与区域相关的U01项目的操作程序(SOP)，以确保高 高质量、可重复的数据集。我们将为研究设计和数据分析提供生物统计学支持，以确保 在该网络内进行的免疫治疗临床试验是经过战略性设计和适当的 以最快的方式获得有意义的临床和实验室数据结果。著名的 宾夕法尼亚大学在人类和狗的临床试验中的专业知识将促进快速翻译 人类临床研究设计和分析的最新方法狗的临床试验和结果 犬类试验可以迅速为人类临床试验提供信息，从而优化这两个物种的结果。最后，这所大学 宾夕法尼亚大学是癌症免疫疗法的领先者，也是世界知名的免疫专家的故乡。 试剂开发和免疫学监测。我们将利用这一专业知识来加快 U24的使命，并通过为相关应用的免疫试剂开发提供支持来扩展它 研究和生物标记物鉴定。我们与U01调查人员、扶贫委员会和督导委员会合作， 将设计、生成和验证多个多参数、多颜色流动板和SOP，以供在 U01站点。成功的免疫监测将使犬癌患者能够简化为单身或 联合疗法最有可能是有效的，并将为未来的翻译提供必要的洞察力 适用于人类癌症患者。

The primary mission of goal of the Pre-medical Cancer Immunotherapy Network for Canine Trials (PRECINCT) is to facilitate the performance of immunotherapy clinical trials in dogs with cancer and to expedite the identification of immunological correlates of successful therapeutic responses. The PRECINCT will achieve these goal by supporting a highly coordinated clinical trials network of participating U01 sites. As a coordinating center, the PRECINCT will work in consultation with U01 investigators, the Steering Committee, representatives from the Comparative Oncology Program (COP) at NCI and an External Advisory Committee to provide expert services in project management and research technology, data management, biostatistical support and immunological monitoring. Specifically, we will establish a PRECINCT Data Coordinating Center to provide comprehensive project oversight, supervise all project management and regulatory compliance activities, and coordinate site management for all aspects of single and large multi-site projects. Through the PRECINCT, U01 investigators will have ready access to research services and standardized protocols that will facilitate the performance of clinical research across the PRECINCT. We will establish a PRECINCT Data Management System to collect, store and share all clinical and correlative data amongst the U01 sites and with the COP directors and Steering Committee. We will develop the infrastructure necessary to achieve an efficient, highly functioning coordinated network and develop standard operating procedures (SOPs) that can be applied across all PRECINCT-associated U01 projects to ensure high quality, repeatable data sets. We will provide biostatistical support for study design and data analysis to ensure that immunotherapy clinical trials performed within the network are strategically designed and appropriately powered to achieve meaningful clinical and laboratory data results in the most expedite way. The renowned expertise of the University of Pennsylvania in both human and canine clinical trials will foster rapid translation of state-of-the art methods for human clinical study design and analysis to canine clinical trials and results from canine trials can rapidly inform human clinical trials, thus optimizing results for both species. Finally, the University of Pennsylvania is a leader in cancer immunotherapy and is also home to world renowned experts in immune reagent development and immunological monitoring. We will leverage this expertise to both accelerate the mission of the U24 and extend it by providing support for immunologic reagent development for use in correlative studies and biomarker identification. In concert with U01 investigators, the COP and the Steering Committee, we will design, generate and validate several multiparametric, multicolor flow panels and SOPs for their use across the U01 sites. Successful immunologic monitoring will allow canine cancer patients to be streamlined to single or combination therapies most likely to be effective and will provide essential insight for future translational application to human cancer patients.