Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
2016年4月27日 更新者：Weill Medical College of Cornell University
The purpose of this study is to learn about the effects of smoking shisha on the lungs, when compared to the effects of smoking cigarettes or of not smoking.
The investigators hope to learn more about how shisha smokers should be monitored and treated once diseased.
研究概览
地位
完全的
条件
详细说明
Traditional shisha smoking is practiced by ~10% of the Qatari adult population.
Although based on tobacco leaves, shisha smoking exposes the airway epithelium to a chemical insult of intensity and duration different from that of cigarette smoking.
This study, a collaboration between WCMC-Qatar and WCMC-New York and the Hamad Medical Corporation (HMC), is focused on defining the biology of the airway epithelium of shisha smokers compared to non-smokers.
Using approved protocols, bronchoscopy will be used to sample the airway epithelium, the site of the earliest changes associated with smoking.
The transcriptome of the recovered epithelium will be assessed in the genomic core WCMC-Qatar for gene expression using microarrays and complete RNA sequencing using massive parallel sequencing.Based on this information, the epithelial DNA will be assessed for relevant SNPs, copy number variations and methylation status.
Parallel studies will be carried out in cigarette smokers, providing a comprehensive catalog of shisha smoking-induced changes compared to cigarette smokers and non-smokers in this population.
研究类型
观察性的
注册 (实际的)
64
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Doha、卡塔尔
- Hamad Medical Corporation
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.
描述
Non-smoker
Inclusion Criteria:
- Population living in Qatar
- Must provide informed consent
- Individuals must also have smoked less than 100 cigarettes and/or less than 10 shisha pipes in their lifetime
- Has normal pulmonary function test
- Has normal chest xray
- No signs of acute lung infection
Exclusion Criteria:
- Medical history of significant illness or other significant medical issues
- Regular shisha smoker
- Regular cigarette smoker
- Simultaneous cigarette plus shisha smoking
Shisha smoker
Inclusion Criteria:
- Population living in Qatar
- Must provide informed consent
- Must have smoked 5 pipe-yr
- Must currently smoke 5 pipes/wk
- Has normal function tests
- Has normal chest xray
- No signs of acute lung infection
Exclusion Criteria:
- Medical history of significant illness or other significant medical issues
- Regular cigarette smoker
- Simultaneous cigarette plus shisha smoking
Cigarette smoker
Inclusion Criteria:
- Population living in Qatar
- Must provide informed consent
- Confirmation of smoking status by urine testing
- Confirmation of smoking status by assessment of carboxyhemoglobin
- Has normal function tests
- Has normal chest xray
- No signs of acute lung infection
Exclusion Criteria:
- Medical history of significant illness or other significant medical issues
- Regular shisha smoker
- Simultaneous cigarette plus shisha smoking
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
|
Non-smoker
This group will include individuals without any history of lung disease, including asthma, and without recurrent or acute pulmonary disease.
Individuals must also have smoked less than 100 cigarettes and/or less than 10 shisha pipes in their lifetime.
|
|
Shisha smoker
This group will include individuals who have a shisha smoking history of more than 5 pipe-years and must currently smoke more than 5 pipes per week.
Individuals must not show any signs of acute lung infection or have medical history of significant illness or other significant medical issues.
|
|
Cigarette smoker
This group will include individuals who have a cigarette smoking history that will be confirmed by urine testing.
Individuals must not show any signs of acute lung infection or have medical history of significant illness or other significant medical issues.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gene expression changes in the small airway epithelium (SAE)
大体时间：3 days
|
We will measure the effect that shisha smoking has on the small airway epithelium (SAE) by measuring parameters such as the SAE gene expression in shisha smokers (i.e., non-cigarette smokers).
We will compare these parameters to the same parameters measured in non-smokers and cigarette smokers.
|
3 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew Walters, PhD、Weill Medical College of Cornell University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年1月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2013年11月22日
首先提交符合 QC 标准的
2013年12月19日
首次发布 (估计)
2013年12月27日
研究记录更新
最后更新发布 (估计)
2016年4月29日
上次提交的符合 QC 标准的更新
2016年4月27日
最后验证
2016年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 13-00055 [JIRB]
- NPRP 09-742-3-194 (其他标识符：Qatar National Research Fund)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.