The MW Cancer Prevention Clinical Trials Network

MW 癌症预防临床试验网络

• 批准号: 10704531
• 负责人: Lisa M Barroilhet
• 金额: $ 162.76万
• 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/10704531
• 关键词: Acceleration; 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; Dose; Dysplasia; Formulation; Funding; Genetic Predisposition to Disease; Goals; Histologic; Immunologics; Immunoprevention; Individual; Infrastructure; Institution; Intervention; Investments; Lead; Malignant Neoplasms; Medical center; Minority Groups; Molecular Target; National Cancer Institute; Neoplasms; Organ; Organizational Affiliation; Participant; Patients; Performance; Pharmacodynamics; Phase; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention program; Prevention trial; Preventive; Preventive measure; Principal Investigator; Process; Productivity; Puerto Rico; Recommendation; Recording of previous events; Reproducibility; Research; Research Personnel; Risk; Science; Screening procedure; Site; Special Population; Testing; Time; Tissues; Underrepresented Minority; Universities; Vaccines; Wisconsin; cancer care; cancer chemoprevention; cancer clinical trial; cancer prevention; cancer therapy; clinical effect; clinically relevant; clinically significant; cost effective measures; design; drug repurposing; epidemiologic data; experience; first-in-human; healthy volunteer; high risk; high risk population; improved; innovation; medical specialties; member; multidisciplinary; novel; phase I trial; pilot trial; prevent; prevention clinical trial; research clinical testing; targeted agent; tumor progression; vaccine trial; Acceleration; 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; Dose; Dysplasia; Formulation; Funding; Genetic Predisposition to Disease; Goals; Histologic; Immunologics; Immunoprevention; Individual; Infrastructure; Institution; Intervention; Investments; Lead; Malignant Neoplasms; Medical center; Minority Groups; Molecular Target; National Cancer Institute; Neoplasms; Organ; Organizational Affiliation; Participant; Patients; Performance; Pharmacodynamics; Phase; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention program; Prevention trial; Preventive; Preventive measure; Principal Investigator; Process; Productivity; Puerto Rico; Recommendation; Recording of previous events; Reproducibility; Research; Research Personnel; Risk; Science; Screening procedure; Site; Special Population; Testing; Time; Tissues; Underrepresented Minority; Universities; Vaccines; Wisconsin; cancer care; cancer chemoprevention; cancer clinical trial; cancer prevention; cancer therapy; clinical effect; clinically relevant; clinically significant; cost effective measures; design; drug repurposing; epidemiologic data; experience; first-in-human; healthy volunteer; high risk; high risk population; improved; innovation; medical specialties; member; multidisciplinary; novel; phase I trial; pilot trial; prevent; prevention clinical trial; research clinical testing; 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措施以防止癌症的需求是自我宣传的。大学 威斯康星州（UWISC）作为主要学术组织（LAO）以及我们的合作机构 （附属组织/AOS）提议继续进行早期癌症预防试验， 癌症预防司（DCP）国家癌症研究所（NCI）作为癌症预防临床试验 如RFA-CA-18-031中所述，网络（CP-CTNET）站点以UG1财团资助。我们的总体目标 是为了评估新型预防剂/干预措施对相关生物学终点的影响 有效地确定其对进一步测试的适当性和潜在的生存能力 推荐的社会干预措施减轻了癌症的伯恩。我们将通过 以下特定目的：（1）有效设计，进行和执行0、1、2化学预防临床 新颖和/或重新塑造的基于免疫学或分子靶向剂的试验，评估其对其对 相关生物学（生物标志物/临床效应）终点。 （2）建立在现有的财团基础设施上 通过与内部或内部或跨内部（CP-CTNET）多机构合作完成目标1 NCI/DCP贡献了三到四个新阶段0、1或2次临床试验，准确性≥40-50受试者。 由于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（联盟成员目前持有> 90个DCP赞助R，U或Destract奖励）和 我们财团的人员配备，组织和管理，导致及时发展，绩效 并完成有影响力的多机构早期癌症预防试验。我们增强的财团 由> 10个NCI指定的癌症中心组成 患者（例如，梅奥诊所，西雅图癌症护理联盟），并扩大了对处于危险不足的处于危险的机会 少数民族和特殊人口（例如，阿拉斯加本地医学中心波多黎各大学）。支持 威斯康星大学CP-CTNET网站Carbone Cancer Center决心为前进做出贡献 通过早期预防试验的性能预防癌症的领域。