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

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.

摘要 需要提供安全和具有成本效益的措施来预防癌症是不言自明的。大学 威斯康星州（UWISC）作为牵头学术组织（LAO）与我们的合作机构一起 （附属组织/AO）建议继续进行早期癌症预防试验， 国家癌症研究所（NCI），癌症预防部（DCP），作为癌症预防临床试验 如RFA-CA-18-031所述，作为UG 1联盟资助的网络（CP-CTNET）站点。我们的总目标 评价新型预防剂/干预措施对相关生物学终点的影响， 有效地确定其进一步测试的适当性和成为 建议采取社会干预措施减轻癌症负担。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0、1、2期化学预防临床试验 新的和/或重新利用的免疫学或分子靶向药物的试验，评估其对 相关生物学（生物标志物/临床效应）终点。(2)在现有联盟基础设施的基础上， 通过联盟内或联盟间（CP-CTNET）多机构合作，与 NCI/DCP贡献了3 - 4项新的0、1或2期临床试验，每年招募≥ 40-50例受试者。 由于我们在预防方面的综合经验， 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）， 我们的联合体的人员配备，组织和管理，从而及时开发，性能 完成有影响力的多机构早期癌症预防试验。我们增强的联盟 由>10个国家癌症研究所指定的癌症中心组成，这些机构提供大量的高危人群， 患者（例如，马约诊所、西雅图癌症护理联盟），并扩大了对代表性不足的高危患者的访问 少数民族和特殊人群（如波多黎各大学、阿拉斯加土著医疗中心）。支持 威斯康星州大学Carbone癌症中心CP-CTNet站点决心为推进 通过开展早期预防试验来预防癌症。