The MW Cancer Prevention Clinical Trials Network

摘要 提供安全和成本效益高的预防癌症措施的必要性不言而喻。伊利诺伊大学 威斯康星大学(UWISC)作为牵头学术组织(LAO)与我们的合作机构 (附属机构/组织)建议继续进行早期癌症预防试验， 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)按照RFA-CA-18-031中所述作为UG1联盟提供资金的站点。我们的首要目标 评估新的预防性药物/干预措施对相关生物终点的影响，以便 有效地确定它们是否适合进一步测试以及成为 建议进行社会干预以减轻癌症负担。我们将通过以下途径实现这一首要目标 以下具体目标：(1)有效地设计、实施和执行0、1、2期化学预防临床 新的和/或改变用途的免疫学或分子靶向药物的试验，评估它们对 相关的生物学(生物标记物/临床效应)终点。(2)在现有财团基础设施的基础上建设 通过联合体内或联合体间(CP-CTNET)多机构协作完成目标1 NCI/DCP每年贡献三到四个新的0期、1期或2期临床试验和≥40-50名受试者的应计费用。 由于我们在预防方面的经验，我们有能力成功地实现上述目标。 代理开发(联盟成员目前持有&gt；90 DCP赞助的R、U或防止奖)和 我们联合体的人员配备、组织和管理，导致了及时的发展、业绩 以及完成有效的、多机构的早期癌症预防试验。我们的增强型联盟 由NCI指定的10个癌症中心组成，这些机构提供大量有风险的 患者(例如梅奥诊所、西雅图癌症护理联盟)和扩大接触高危人群的机会 少数民族和特殊人群(例如波多黎各大学、阿拉斯加土著医学中心)。支持： 威斯康星大学CP-CTnet网站的碳骨癌中心决心为推动 通过开展早期预防试验来预防癌症。

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.