HHSN26120120003 II CLINICAL STUDY OF THE EFFECT OF COMBINED TREATMENT OF ASPIRIN AND ZILEUTON ON BIOMARKERS OF TOBACCO-RELATED CARCINOGENESIS IN CURRENT CMOKERS 08/01/2014 - 07/31/2016

拟议的研究将评估每日阿司匹林81mg /天剂量与zileuton (Zyflo-CR) 2片x600mg / 2次/天相比安慰剂3个月对当前吸烟者鼻上皮中选定的吸烟相关基因表达特征和3种肺癌相关特征的影响，并评估两个研究组之间的任何差异。这项研究是评估阿司匹林和zileuton （Zyflo-CR）是否有助于预防肺癌的更大努力的早期步骤。试验将在亚利桑那大学进行，亚利桑那大学将负责参与者招募、患者护理、数据分析、报告准备和稿件准备。波士顿大学（a . Spira博士的小组）是本研究的合作者之一，将负责所有基因特征相关的分析，另一位研究合作者加州大学戴维斯分校的Jun Young博士负责花生四烯酸（AA）代谢组学分析。

The proposed study shall assess the effects of daily aspirin 81 mg per day dose given along with zileuton (Zyflo-CR) 2 tablets x 600 mg each twice a day versus placebo for 3 months on selected smoking-related gene expression signature and three lung cancer-related signatures in the nasal epithelium of current smokers, and to evaluate any difference between both study arms. This study is an early step in larger effort to evaluate whether or not aspirin plus zileuton (Zyflo-CR) could be useful in prevention of lung cancer. The trial shall be performed at the University of Arizona, which shall be responsible for participant recruitment, patient care, data analysis, report preparation, and manuscript preparation. Boston University (Dr. A. Spira’s group), a collaborator on this study, shall be responsible for all gene signatures related analyses with Dr. Jun Young, Ph.D. from UC Davis, another study collaborator, being responsible for arachidonic acid (AA) metabolomics analyses.