A PHASE II EXPLORATORY, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF POMEGRANATE FRUIT

石榴果的 II 期探索性、随机、安慰剂对照试验

• 批准号: 8762640
• 负责人: KIRK WEEKS
• 金额: $ 48.82万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-24 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8762640
• 关键词: Apoptosis; Biological; Clinical; Clinical Trials; Contractor; Development; Division of Cancer Prevention; Drug Industry; Fruit; Growth Factor; Institution; Intraepithelial Neoplasia; Laboratories; Malignant Neoplasms; Molecular Target; Monitor; National Cancer Institute; Oncogenes; Organ; Participant; Patients; Phase; Phase II Clinical Trials; Pomegranate; Preventive; Research Infrastructure; Site; Specific qualifier value; body system; cancer prevention; carcinogenesis; clinically relevant; design; insight; novel; prevention clinical trial; programs; randomized placebo controlled trial; response

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（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应。待研究的制剂包括由制药行业开发并提供给DCP进行合作开发的制剂、市售制剂和DCP开发的制剂。该计划要求建立稳定的临床试验基础设施，以支持约75名或更多受试者参加0-II期临床试验，重点主要是II期试验。将在多个器官系统中进行不同复杂程度的试验。临床试验将在承包商的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，包括累积机构的患者水平监测。