A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Indiv
A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Indiv
批准号:
9251705
负责人:
POWELL BROWN, MD
金额:
$1.39万
依托单位国家:
美国
项目类别:
财政年份:
2013
资助国家:
美国
项目状态:
已结题
起止时间:
2013-09-20 至 2018-09-19
关键词:
AddressAffectAspirinC-reactive proteinClinical TrialsCotinineDoseEuropeanGoalsInstitutesItalyLesionLeukotriene E4LeukotrienesLung AdenocarcinomaLung noduleMalignant neoplasm of lungMicroRNAsMonitorNodulePatientsPhasePlacebosPreventionProstaglandinsRandomizedSerumSmokerSolidSpiral Computed Tomographycohortdensitydouble-blind placebo controlled trialhigh riskoncologyphase II trialscreeningurinary
中文摘要
拟议的临床试验将讨论阿司匹林在预防肺腺癌方面是否有效。这是一项IIb期随机安慰剂对照的双盲试验,阿司匹林每天100毫克,在意大利米兰的欧洲肿瘤研究所参加螺旋CT筛查试验的现任和前任吸烟者为期1年。目的是确定小剂量阿司匹林是否影响CT确定的非固体或部分固体持久性肺结节的大小,因为这些结节的子集代表肺癌的先兆。临床试验将在欧洲肿瘤学研究所进行,由MD Anderson提供监测和监督。
英文摘要
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.
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