The MW Cancer Prevention Clinical Trials Network

MW 癌症预防临床试验网络

• 批准号: 10252839
• 负责人: HOWARD H. BAILEY
• 金额: $ 171.64万
• 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/10252839
• 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; Immunoprevention; Individual; Infrastructure; Institution; Intervention; Investments; Lead; Malignant Neoplasms; Medical center; Minority Groups; Molecular Target; National Cancer Institute; Neoplasms; Organ; Participant; Patients; Performance; 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; Special Population; Testing; Time; Tissues; Underrepresented Minority; Universities; Vaccines; Wisconsin; base; cancer care; cancer chemoprevention; cancer clinical trial; cancer prevention; 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; 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.

摘要