Coordinating Center for Canine Immunotherapy Trials and Correlative Studies

犬免疫治疗试验及相关研究协调中心

• 批准号: 10255532
• 负责人: Qi Long
• 金额: $ 56.8万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255532
• 关键词: Administrative Coordination; Advisory Committees; Area; Biological Assay; Biological Markers; Biometry; Biostatistical Methods; Cancer Patient; Canis familiaris; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Collaborations; Combined Modality Therapy; Communities; Consult; Consultations; Correlative Study; Data; Data Analyses; Data Coordinating Center; Data Element; Data Management Resources; Data Set; Databases; Deposition; Development; Elements; Ensure; Fostering; Future; General Population; Goals; Home; Human; Immune; Immune response; Immunologic Markers; Immunologic Monitoring; Immunologics; Immunologist; Immunotherapeutic agent; Immunotherapy; Infrastructure; Laboratories; Laboratory Study; Malignant Neoplasms; Methods; Mission; Monitor; Pennsylvania; Performance; Phenotype; Procedures; Production; Productivity; Protocols documentation; Reagent; Research; Research Design; Research Personnel; Resources; Scientist; Secure; Services; Site; Standardization; Supervision; T-Lymphocyte; Technology; Translations; Universities; Work; assay development; base; biomarker identification; cancer immunotherapy; clinical predictors; comparative; data management; design; experience; immunotherapy clinical trials; immunotherapy trials; innovation; insight; medical schools; member; oncology program; operation; participant enrollment; predictive marker; research study; response; tool; translational study; treatment response; trial design; tumor microenvironment

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.

医疗前癌症免疫疗法网络的主要使命是犬类试验（区域），以促进癌症狗的免疫疗法临床试验的性能，并加快鉴定 成功治疗反应的免疫学相关性。该地区将通过支持高度协调的参与U01站点的临床试验网络来实现这些目标。作为一个协调中心，该区将与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协商，以提供项目管理和研究技术，数据管理，生物统计学支持和免疫学监测的专家服务。 具体来说，我们将建立一个区域数据协调中心，以提供全面的项目监督， 监督所有项目管理和监管合规活动，并协调所有人的站点管理 单一和大型多站点项目的各个方面。通过该区域，U01调查人员将准备好使用研究服务和标准化协议，以促进整个临床研究的性能 区域。我们将建立一个区域数据管理系统，以收集，存储和共享所有临床和 U01站点以及COP董事和指导委员会之间的相关数据。我们将发展 实现高效，高度运行的协调网络所必需的基础架构并建立标准 可以在所有与区域相关的U01项目中应用的操作程序（SOP），以确保高 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 网络中进行的免疫疗法临床试验是战略性设计和适当的 有助于实现有意义的临床和实验室数据以最快的方式产生。著名的 宾夕法尼亚大学在人类和犬临床试验中的专业知识将促进 人类临床研究设计和分析的最先进方法，用于犬临床试验和结果 犬试验可以迅速为人类临床试验提供信息，从而优化两种物种的结果。最后，大学 宾夕法尼亚州是癌症免疫疗法的领导者，也是世界著名专家免疫专家 试剂开发和免疫学监测。我们将利用这种专业知识来加速 U24的任务并通过为免疫试剂开发提供支持来扩展其用于相关性 研究和生物标志物鉴定。在与U01调查员，警察和指导委员会的一致 将设计，生成和验证几个多功能，多色流动面板和SOP，以便在整个 U01站点。成功的免疫监测将使犬类癌患者可以简化为单一或 组合疗法最有可能有效，并将为将来的翻译提供必要的见解 适用于人类癌症患者。