University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet)

亚利桑那大学癌症预防临床试验网络 (UA CP-CTNet)

基本信息

批准号：
10684914
负责人：
Julie E Bauman
金额：
$ 150.7万
依托单位：
UNIVERSITY OF ARIZONA
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-16 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10684914
关键词：
Affect Arizona Biochemical Biological Biological Markers Chemoprevention Chronic Disease Clinical Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Contracts Data Development Dose Drug Delivery Systems Evaluation Foundations Funding Genomics Human Resources Immune Immunologic Surveillance Immunomodulators Immunoprevention Incidence Intercept Lead Leadership Lesion Longterm Follow-up Lung Malignant Female Reproductive System Neoplasm Malignant Neoplasms Malignant neoplasm of gastrointestinal tract Malignant neoplasm of prostate Manuscripts Metabolic Molecular Molecular Target Normal tissue morphology Nutraceutical Organ Organizational Affiliation Participant Pathologist Pathway interactions Phase Physicians Preparation Preventive Process Regulation Research Safety Schedule Site Skin Carcinoma Surrogate Endpoint Tissues Translational Research Universities Urologic Cancer Work biomarker identification cancer clinical trial cancer invasiveness cancer prevention carcinogenesis clinical development clinically relevant design drug repurposing early phase clinical trial efficacy trial epidemiology study experience insight interest malignant breast neoplasm medical specialties melanoma new technology novel pharmacokinetics and pharmacodynamics phase III trial potential biomarker preclinical study premalignant prevention clinical trial primary endpoint protocol development response skin cancer prevention surveillance network translational scientist

项目摘要

PROJECT SUMMARY Advances in molecular understanding of the process of carcinogenesis have led to the study of an increasing number of agents to intercept the early phases of cancer development, including the recent interest in immunoprevention. The overall objective of University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) is to perform early phase clinical trials to evaluate the biologic effects of putative preventive agents and to determine clinically relevant correlates in order to identify agents with good safety profiles and preliminary efficacy for definitive Phase III trials. The UA CP-CTNet consists of a team of physicians from diverse specialties, statisticians, clinical staff, data managers, pathologists, translational scientists, and other personnel with extensive experience in early phase clinical trials of cancer preventive agents and in translational research in various organ sites. Specifically, the UA CP-CTNet will: • Efficiently design and conduct Phase 0/I/II clinical trials to assess the cancer preventive potential of repurposed drugs that affect multiple chronic diseases, well-characterized nutraceutical agents, regional/topical drug delivery, and immune modulators, identified from translational research, epidemiological studies, and/or clinical research. • Characterize the clinical activity and biological effects of putative cancer preventive agents on their defined molecular/biochemical targets, the immune surveillance network, surrogate endpoints associated with carcinogenesis, and other biological effect markers identified in preclinical studies. • Develop further scientific insights into the mechanisms of cancer prevention by the agents studied and to develop novel potential markers as determinants of response and for selecting subpopulations who may differentially benefit from the studied agent. Through the proposed research, we expect to conduct rigorously designed early phase cancer prevention clinical trials that determine the clinical activity and biological effects of potential preventive agents. The research findings will further scientific insights into the mechanisms of cancer prevention and develop novel potential biomarkers as determinants of response. Scientific and clinical evidence generated from these early phase cancer prevention clinical trials will contribute significantly to “go-no go” decisions for further clinical development of putative agents for cancer prevention.

项目摘要分子理解癌变过程的进步导致研究了不满的研究拦截癌症发展早期阶段的代理数量，包括最近对免疫预防。 CP-CTNET）是执行早期阶段clials来评估推定预防剂的生物学效应并确定临床相关的相关性，以便识别具有良好安全性和初步性的药物确定性III期试验的功效。 UA CP-CTNET由来自不同专业，统计学家，临床人员，数据的医生组成经理，病理学家，转化科学家和其他具有经验早期经验的人员癌症预防剂和各种器官转化研究的临床试验。具体而言，UA CP-CTNET将： •有效设计和进行0/I/II临床试验，以评估预防癌症的潜在重新利用的药物会影响多种慢性疾病，表征良好的营养剂，从转化研究中确定的区域/局部药物输送和免疫调节器，流行病学研究和/或临床研究。 •表征假定癌症预防的临床活性和生物学作用定义的分子/生化靶标，免疫监视网络，替代端点相关临床前研究中确定的癌变和其他生物效应标记。 •开发人员对癌症机制的科学见解开发新的潜在标记作为响应的决定因素，并选择可能会从研究的代理中受益。通过支撑研究，我们期望进行严格设计的早期癌症预防临床确定潜在预期药物的临床活性和生物学作用的试验调查结果将进一步科学见解预防癌症的机制，并发展出新颖的Potel Potel潜力生物标志物作为反应的决定因素。癌症预防临床试验将为进一步的临床发展做出重大贡献推定的预防癌症的药物。