A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Indiv

低剂量阿司匹林与安慰剂在高危个体中的随机 II 期试验

• 批准号: 8762957
• 负责人: TERISA DAVIS
• 金额: $ 109.44万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2016-09-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8762957
• 关键词: Address; Affect; Aspirin; C-reactive protein; Clinical Trials; Cotinine; Dose; European; Goals; Institutes; Italy; Lesion; Leukotriene E4; Leukotrienes; Lung Adenocarcinoma; Lung nodule; Malignant neoplasm of lung; MicroRNAs; Monitor; Nodule; Patients; Phase; Phase II Clinical Trials; Placebos; Prevention; Prostaglandins; Randomized; Serum; Smoker; Solid; Spiral Computed Tomography; cohort; density; double-blind placebo controlled trial; high risk; oncology; screening; urinary

The proposed clinical trial shall address whether aspirin has utility in the prevention of lung adenocarcinoma. It is a phase IIb randomized placebo controlled, double blind trial of aspirin 100 mg per day given for 1 year to current and former smokers participating in helical CT screening trials at the European Institute of Oncology in Milan, Italy. The goal is to determine if low dose aspirin affects the size of non-solid or partially solid persistent lung nodules identified by CT, since a subset of these nodules represent precursors to lung cancer. The clinical trial shall be performed at the European Institute of Oncology, with monitoring and oversight provided by MD Anderson.

拟议的临床试验应探讨阿司匹林是否在预防肺腺癌方面具有效用。这是一项IIb期随机安慰剂对照双盲试验，每天服用阿司匹林100毫克，持续1年，在意大利米兰的欧洲肿瘤研究所参加螺旋CT筛查试验。目的是确定低剂量阿司匹林是否会影响CT识别的非实性或部分实性持续性肺结节的大小，因为这些结节中的一部分代表肺癌的前兆。临床试验将在欧洲肿瘤研究所进行，由MD安德森提供监测和监督。