CP-CTNet Coordinating Center

CP-CTNet协调中心

• 批准号: 10455715
• 负责人: KyungMann Kim
• 金额: $ 247.66万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10455715
• 关键词: Apoptosis; Biological; Biometry; Cancer Burden; Canes; Cell Proliferation; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Community Clinical Oncology Program; Complement; Data Reporting; Databases; Development; Division of Cancer Prevention; Dose; Event; Goals; Growth Factor; Immune response; Informatics; Information Technology; Intervention; Leadership; Leg; Logistics; Malignant Neoplasms; Management Audit; Methodology; Molecular Target; Morbidity - disease rate; National Cancer Institute; Oncogenes; Pattern; Phase; Preclinical Drug Development; Prevention trial; Preventive; Process; Program Development; Research; Resources; Risk; Role; Safety; Site; Statistical Data Interpretation; Toxicology; Training; cancer prevention; carcinogenesis; clinical development; cost effective; data management; design; early phase clinical trial; early phase trial; effective intervention; efficacy clinical trial; innovation; insight; mortality; novel; oncology trial; operation; phase III trial; pre-clinical; prevention clinical trial; programs; protocol development; recruit; response; trend; virtual

Project Summary/Abstract Cancer is the leading cause of morbidity and mortality in the US and in the world. One approach to reducing the risk and burden of cancer is to use preventive agents and interventions that are effective and safe. According to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI), this requires the systematic development of cancer preventive agents and interventions, with three critical components; i) preclinical/toxicology studies for identification of agents, ii) early phase trials of identified agents and other promising interventions, and iii) late phase III trials of preventive agents and interventions that have successfully passed through early phase trials, in a three-legged approach. The goal of the Cancer Prevention Clinical Trials Network (CP-CTNet) is to identify safe and effective preventive agents and interventions in order to advance their further clinical development for cancer prevention. Further clinical development is to be undertaken in late phase III trials conducted by the third leg, i.e. the National Community Oncology Research Program (NCORP), supported by the DCP's Community Oncology and Prevention Trials Research Group, to ultimately reduce the risk and burden of cancer. As the second leg of this three-legged approach, the CP-CTNet will conduct early phase trials to assess the safety, tolerability, and cancer preventive potential of agents and interventions of varying classes identified by the first leg, i.e. the DCP's Cancer Preclinical Drug Development Program (PREVENT) support of preclinical/toxicology studies, many of which target molecules or processes known to be important during carcinogenesis. The CP- CTNet Sites will perform these early phase trials supported by the DCP and the CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC). These trials include phase 0 (micro-dosing), phase I (dose- finding), and phase II (preliminary efficacy) clinical trials. To support these early phase trials, which will be conducted by the CP-CTNet sites alone or as cross-Network trials, the CP-CTNet DMACC will coordinate trans-Network activities and provide expertise and resources in 1) centralized data management and reporting, 2) clinical trials auditing, and 3) administrative and logistical coordination, including expertise in clinical trials methodology and biostatistics, across CP-CTNet. In addition, the CP-CTNet DMACC will provide an advisory role in early phase caner prevention trial development for all CP-CTNet trials and the primary statistical role for cross-Network trials.

项目概要/摘要 癌症是美国乃至全世界发病率和死亡率的主要原因。一种减少方法 癌症的风险和负担在于使用有效且安全的预防药物和干预措施。 根据美国国家癌症研究所 (NCI) 癌症预防部门 (DCP) 的说法，这需要 系统地开发癌症预防剂和干预措施，包括三个关键组成部分；我） 用于鉴定药物的临床前/毒理学研究，ii) 已鉴定药物和其他药物的早期阶段试验 有前景的干预措施，以及 iii) 预防药物和干预措施的后期 III 期试验 以三足方式成功通过早期试验。 癌症预防临床试验网络 (CP-CTNet) 的目标是确定安全有效的 预防药物和干预措施，以促进癌症的进一步临床开发 预防。进一步的临床开发将在第三阶段进行的后期 III 期试验中进行， 即国家社区肿瘤学研究计划 (NCORP)，由 DCP 社区支持 肿瘤学和预防试验研究小组，最终降低癌症的风险和负担。作为 作为这一三步走方法的第二步，CP-CTNet 将进行早期试验以评估安全性， 第一个确定的不同类别的药物和干预措施的耐受性和癌症预防潜力 腿，即 DCP 的癌症临床前药物开发计划 (PREVENT) 对临床前/毒理学的支持 研究，其中许多针对已知在致癌过程中重要的分子或过程。 CP- CTNet 站点将在 DCP 和 CP-CTNet 数据管理的支持下执行这些早期试验， 审计和协调中心 (DMACC)。这些试验包括 0 期（微剂量）、I 期（剂量- 发现）和II期（初步疗效）临床试验。 为了支持这些早期试验，这些试验将由 CP-CTNet 站点单独或跨网络进行 试验期间，CP-CTNet DMACC 将协调跨网络活动并提供以下方面的专业知识和资源：1) 集中数据管理和报告，2) 临床试验审核，以及 3) 行政和后勤 跨 CP-CTNet 的协调，包括临床试验方法和生物统计学方面的专业知识。此外， CP-CTNet DMACC 将为所有人提供早期癌症预防试验开发的咨询服务 CP-CTNet 试验和跨网络试验的主要统计作用。