- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02021708
Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
April 27, 2016 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Doha, Qatar
- Hamad Medical Corporation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression changes in the small airway epithelium (SAE)
Time Frame: 3 days
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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.
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3 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthew Walters, PhD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
November 22, 2013
First Submitted That Met QC Criteria
December 19, 2013
First Posted (Estimate)
December 27, 2013
Study Record Updates
Last Update Posted (Estimate)
April 29, 2016
Last Update Submitted That Met QC Criteria
April 27, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 13-00055 [JIRB]
- NPRP 09-742-3-194 (Other Identifier: Qatar National Research Fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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