SmokingNCT02021708
Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
An observational study of Smoking, run by Weill Medical College of Cornell University at 1 site in Qatar.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 64 participants
- Where
- 1 siteQatar
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- Medical history of significant illness or other significant medical issues
- Regular shisha smoker
- Regular cigarette smoker
- Simultaneous cigarette plus shisha smoking
- Shisha smoker
- Medical history of significant illness or other significant medical issues
Show all 12Show fewer
- Regular cigarette smoker
- Simultaneous cigarette plus shisha smoking
- Cigarette smoker
- Medical history of significant illness or other significant medical issues
- Regular shisha smoker
- Simultaneous cigarette plus shisha smoking
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression changes in the small airway epithelium (SAE)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Matthew Walters, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021708
- Sponsor's protocol ID
- 13-00055 [JIRB]
- Other IDs
- NPRP 09-742-3-194
- Status last verified
- Apr 2016
- First submitted
- 22 Nov 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
- ClinicalTrials.gov ID
- NCT02021708
- Acronym / sponsor ID
- 13-00055 [JIRB]
- Conditions
- Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (12 listed)
- Medical history of significant illness or other significant medical issues
- Regular shisha smoker
- Regular cigarette smoker
- Simultaneous cigarette plus shisha smoking
- Shisha smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene expression changes in the small airway epithelium (SAE)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Walters, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Weill Medical College of Cornell University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression changes in the small airway epithelium (SAE) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.