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: 10247892
• 负责人: Qi Long
• 金额: $ 56.73万
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247892
• 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; Enrollment; Ensure; Fostering; Future; General Population; Goals; Home environment; Human; Immune; Immune response; Immunologic Markers; Immunologic Monitoring; Immunologics; Immunologist; Immunotherapeutic agent; Immunotherapy; Infrastructure; Laboratories; Laboratory Study; Malignant Neoplasms; Methods; Mission; Monitor; Patients; 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; 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.

犬类试验医学前癌症免疫治疗网络 (PRECINCT) 的主要使命是促进在患有癌症的犬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。 PRECINCT 将通过支持参与 U01 站点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，PRECINCT 将与 U01 研究人员、指导委员会、NCI 比较肿瘤学项目 (COP) 的代表以及外部咨询委员会协商，在项目管理和研究技术、数据管理、生物统计等方面提供专家服务。支持和免疫监测。 具体来说，我们将建立一个 PRECINCT 数据协调中心来提供全面的项目监督、 监督所有项目管理和法规合规活动，并协调所有人员的现场管理 单个和大型多站点项目的各个方面。通过 PRECINCT，U01 研究人员将可以随时获得研究服务和标准化协议，这将促进整个临床研究的进行 辖区。我们将建立 PRECINCT 数据管理系统来收集、存储和共享所有临床和 U01 站点之间以及 COP 主管和指导委员会的相关数据。我们将开发 实现高效、高效的协调网络和制定标准所必需的基础设施 可应用于所有 PRECINCT 相关 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支持，以确保 在网络内进行的免疫治疗临床试验是经过战略设计和适当的 能够以最快捷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犬类临床试验方面的专业知识将促进快速转化 最先进的人类临床研究设计和分析犬临床试验及其结果的方法 犬类试验可以快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，大学 宾夕法尼亚州是癌症免疫治疗领域的领导者，也是世界知名免疫专家的故乡 试剂开发和免疫学监测。我们将利用这些专业知识来加速 U24 的使命，并通过为相关免疫试剂开发提供支持来扩展它 研究和生物标志物鉴定。我们与 U01 调查人员、缔约方会议和指导委员会合作， 将设计、生成和验证多个多参数、多色流程面板和 SOP，以供其在整个行业中使用 U01站点。成功的免疫监测将使犬癌症患者简化为单一或 联合疗法最有可能有效，并将为未来的转化提供重要的见解 应用于人类癌症患者。