Chemoprevention Clinical Trial of Pomegranate Fruit Extract in Men

石榴果提取物对男性的化学预防临床试验

• 批准号: 8739533
• 负责人: KIRK WEEKS
• 金额: $ 65.44万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-24 至 2014-09-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739533
• 关键词: Biological Markers; Biopsy; Chemoprevention; Clinical Trials; Fruit; Gleason Grade for Prostate Cancer; Insulin-Like Growth Factor Binding Protein 3; Insulin-Like Growth Factor I; Intervention; Malignant Neoplasms; Malignant neoplasm of prostate; Oral Administration; Participant; Placebos; Plasma; Pomegranate; Protocols documentation; Serum; Somatomedins; Staging; Testing; Time; Toxic effect; cohort; follow-up; men; response; tumor

The National Cancer Institute (NCI), Division of Cancer Prevention (DCP) Phase 0/I/II Cancer Prevention Clinical Trials Program supports early clinical trials to rapidly evaluate the clinical activity and biologic effects of cancer preventive agents. The agents to be studied include agents developed by the pharmaceutical industry and provided to DCP for collaborative development, commercially available agents, and agents developed by DCP. The program requires the establishment of a stable clinical trials infrastructure to support the accrual of approximately 75 or more subjects to phase 0-II clinical trials, with an emphasis primarily on phase II trials. Trials in multiple organ systems and with varying degrees of complexity will be performed. Clinical trials will be performed at the Contractor¿s institution or at one or more collaborating institutions which enhance the capability of the Contractor to conduct these trials. The Contractor will be responsible for the oversight of all studies, including patient-level monitoring of accruing institutions.

美国国家癌症研究所(NCI)癌症预防部门(DCP)0/I/II期癌症预防临床试验计划支持早期临床试验，以快速评估癌症预防药物的临床活性和生物学效果。要研究的试剂包括制药行业开发的并提供给DCP进行协作开发的代理、商业上可用的代理以及DCP开发的代理。该计划要求建立一个稳定的临床试验基础设施，以支持大约75名或更多的受试者参加0-II期临床试验，重点主要是II期试验。将进行多器官系统和不同复杂程度的试验。临床试验将在承包商的S机构或一个或多个合作机构进行，以增强承包商进行这些试验的能力。承包商将负责监督所有研究，包括对累积机构的病人一级监测。