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
基本信息
- 批准号:10247892
- 负责人:
- 金额:$ 56.73万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Administrative CoordinationAdvisory CommitteesAreaBiological AssayBiological MarkersBiometryBiostatistical MethodsCancer PatientCanis familiarisClinicalClinical ResearchClinical TrialsClinical Trials DesignClinical Trials NetworkCollaborationsCombined Modality TherapyCommunitiesConsultConsultationsCorrelative StudyDataData AnalysesData Coordinating CenterData ElementData Management ResourcesData SetDatabasesDepositionDevelopmentElementsEnrollmentEnsureFosteringFutureGeneral PopulationGoalsHome environmentHumanImmuneImmune responseImmunologic MarkersImmunologic MonitoringImmunologicsImmunologistImmunotherapeutic agentImmunotherapyInfrastructureLaboratoriesLaboratory StudyMalignant NeoplasmsMethodsMissionMonitorPatientsPennsylvaniaPerformancePhenotypeProceduresProductionProductivityProtocols documentationReagentResearchResearch DesignResearch PersonnelResourcesScientistSecureServicesSiteStandardizationSupervisionT-LymphocyteTechnologyTranslationsUniversitiesWorkassay developmentbasebiomarker identificationcancer immunotherapyclinical predictorscomparativedata managementdesignexperienceimmunotherapy clinical trialsimmunotherapy trialsinnovationinsightmedical schoolsmemberoncology programoperationpredictive markerresearch studyresponsetooltranslational studytreatment responsetrial designtumor microenvironment
项目摘要
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中进行免疫治疗临床试验,并加快识别
成功的治疗反应的免疫学相关性。PRECINCT将通过支持参与U01研究中心的高度协调的临床试验网络来实现这些目标。作为一个协调中心,PRECINCT将与U01研究者、指导委员会、NCI比较肿瘤学项目(COP)的代表和外部咨询委员会协商,在项目管理和研究技术、数据管理、生物统计支持和免疫监测方面提供专家服务。
具体来说,我们将建立一个PRECINCT数据协调中心,提供全面的项目监督,
监督所有项目管理和法规遵从性活动,并协调所有现场管理
单个和大型多站点项目的各个方面。通过PRECINCT,U01研究者将随时获得研究服务和标准化方案,这将促进整个国家临床研究的开展。
分局我们将建立PRECINCT数据管理系统来收集、存储和共享所有临床和
U01各地点之间以及与COP主任和指导委员会之间的相关数据。我们将开发
建立一个高效、高度运作协调网络所需的基础设施,并制定标准
可应用于所有PRECINT相关U01项目的操作程序(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
在网络内进行的免疫治疗临床试验是战略性设计的,
能够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犬类临床试验方面的专业知识将促进
人类临床研究设计和分析的最新方法,以及犬临床试验和结果
犬试验可以迅速为人类临床试验提供信息,从而优化两个物种的结果。最后,大学
是癌症免疫治疗的领导者,也是世界知名的免疫治疗专家的所在地。
试剂开发和免疫学监测。我们将利用这些专业知识,
U24的使命,并通过为免疫试剂的开发提供支持来扩展它,
研究和生物标志物鉴定。我们与U01调查员、缔约方会议和指导委员会合作,
我将设计、生成和验证几个多参数、多流程面板和SOP,供其在
U01站点。成功的免疫学监测将使犬癌症患者简化为单一或
联合治疗最有可能是有效的,并将提供必要的见解,为未来的翻译
应用于人类癌症患者。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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10457208 - 财政年份:2021
- 资助金额:
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10579286 - 财政年份:2021
- 资助金额:
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整合脑成像和组学数据的阿尔茨海默病进展统计模型
- 批准号:
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Privacy-preserving methods and tools for handling missing data in distributed health data networks
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- 资助金额:
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A comparative analysis of human and canine iNKT cells for ACT
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- 批准号:
10287095 - 财政年份:2017
- 资助金额:
$ 56.73万 - 项目类别:
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 - 财政年份:2017
- 资助金额:
$ 56.73万 - 项目类别:
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:
10260668 - 财政年份:2017
- 资助金额:
$ 56.73万 - 项目类别:
Statistical Methods for Causal Inference in Observational Studies
观察研究中因果推断的统计方法
- 批准号:
8870561 - 财政年份:2015
- 资助金额:
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8443616 - 财政年份:2013
- 资助金额:
$ 56.73万 - 项目类别:
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