The MW Cancer Prevention Clinical Trials Network

MW 癌症预防临床试验网络

• 批准号: 10004825
• 负责人: HOWARD H. BAILEY
• 金额: $ 84.54万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-03 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10004825
• 关键词: Advanced Malignant Neoplasm; Alaska Native; Award; Biological; Biological Markers; Cancer Burden; Cancer Center; Cancer Patient; Cancer Prevention Trial; Chemoprevention; Chemopreventive Agent; Clinic; Clinical; Clinical Chemoprevention; Clinical Trials; Clinical Trials Network; Collaborations; Development; Division of Cancer Prevention; Dysplasia; Formulation; Funding; Genetic Predisposition to Disease; Goals; Histologic; Immunologics; Individual; Infrastructure; Institution; Intervention; Investments; Lead; Malignant Neoplasms; Measures; Medical center; Minority; Molecular Target; National Cancer Institute; Neoplasms; Organ; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacodynamics; Phase; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention trial; Preventive; Preventive measure; Principal Investigator; Process; Puerto Rico; Recording of previous events; Reproducibility; Research; Research Personnel; Risk; Science; Site; Testing; Time; Tissues; Universities; Vaccines; Wisconsin; base; cancer care; cancer chemoprevention; cancer clinical trial; cancer prevention; clinical effect; clinically relevant; clinically significant; cost effective; design; epidemiologic data; experience; first-in-human; healthy volunteer; high risk; high risk population; improved; innovation; medical specialties; member; multidisciplinary; named group; novel; phase I trial; prevent; prevention clinical trial; programs; research clinical testing; screening; targeted agent; tumor progression; vaccine trial

ABSTRACT The need to provide safe and cost-effective measures to prevent Cancer is self-explanatory. The University of Wisconsin (UWISC) as the Lead Academic Organization (LAO) together with our collaborating institutions (Affiliated Organizations/AOs) propose to continue performing early phase cancer prevention trials, for the National Cancer Institute (NCI), Division of Cancer Prevention (DCP), as a Cancer Prevention Clinical Trials Network (CP-CTNET) site funded as a UG1 Consortium as described in RFA-CA-18-031. Our overarching goal is to evaluate the effects of novel preventive agents/interventions on pertinent biological endpoints in order to efficiently determine their appropriateness for further testing and potential viability toward becoming recommended societal interventions to lessen the burden of cancer. We will pursue this overarching goal via the following specific aims: (1) Efficiently design, conduct and perform Phase 0, 1, 2 Chemoprevention Clinical Trials of novel and/or re-purposed immunologic-based or molecular targeted agents, assessing their effects upon relevant biological (biomarkers/clinical effects) endpoints. (2) Build upon existing consortium infrastructure to complete Aim 1 via intra- or inter-consortium (CP-CTNET) multi-institutional collaborations in concert with NCI/DCP contributing three to four new Phase 0, 1 or 2 clinical trials and accrual of ≥ 40-50 subjects per year. We are well positioned to successfully achieve the above aims due to our combined experience with prevention agent development (consortium members currently hold >90 DCP sponsored R, U or PREVENT awards) and our consortium's staffing, organization, and management which results in the timely development, performance and completion of impactful, multi-institutional early phase cancer prevention trials. Our enhanced consortium consists of >10 NCI-designated Cancer Centers, institutions providing access to robust numbers of at-risk patients (e.g. Mayo Clinics, Seattle Cancer Care Alliance) and expanded access to at-risk under-represented minorities and special populations (e.g. University of Puerto Rico, Alaska Native Medical Center). Supported by the Carbone Cancer Center, the University of Wisconsin CP-CTNet site is determined to contribute to advancing the field of Cancer prevention through performance of early phase prevention trials.

抽象的 提供安全且具有成本效益的癌症预防措施的必要性是不言而喻的。 威斯康星州 (UWISC) 作为牵头学术组织 (LAO) 与我们的合作机构 （附属组织/AO）建议继续进行早期癌症预防试验，以 美国国家癌症研究所 (NCI) 癌症预防部门 (DCP) 作为癌症预防临床试验 网络 (CP-CTNET) 站点作为 UG1 联盟资助，如 RFA-CA-18-031 中所述。 是评估新型预防药物/干预措施对相关生物学终点的影响，以便 有效地确定它们是否适合进一步测试以及成为潜在的可行性 建议采取社会干预措施来减轻癌症负担，我们将通过以下方式实现这一总体目标。 具体目标如下： (1) 有效设计、实施和执行第 0、1、2 期化学预防临床 试验新型和/或重新利用的基于免疫学或分子靶向药物，评估其对 (2) 以现有联盟基础设施为基础 通过联盟内部或联盟间 (CP-CTNET) 多机构合作完成目标 1 NCI/DCP 贡献三到四项新的 0、1 或 2 期临床试验，每年招募 ≥ 40-50 名受试者。 凭借我们在预防方面的综合经验，我们有能力成功实现上述目标 代理开发（联盟成员目前拥有超过 90 个 DCP 赞助的 R、U 或 PREVENT 奖项）以及 我们联盟的人员配置、组织和管理导致了及时的发展、绩效 并完成有影响力的多机构早期癌症预防试验。 由超过 10 个 NCI 指定的癌症中心和机构组成，为大量高危人群提供接触机会 患者（例如梅奥诊所、​​西雅图癌症护理联盟）并扩大对高危人群的覆盖范围 少数族裔和特殊人群（例如波多黎各大学、阿拉斯加原住民医疗中心）。 威斯康星大学 Carbone 癌症中心 CP-CTNet 网站决心为推动进步做出贡献 通过进行早期预防试验来预防癌症领域。