AsthmaQ-BCNCT00504361
Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar)
An observational study of Asthma and COPD, run by Weill Medical College of Cornell University at 1 site in Qatar.
Trial summary
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, COPD (chronic obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Interstitial Lung Disease
- How many people
- 600 participants
- Where
- 1 siteQatar
- Study dates
- May 2006to May 2012
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals visiting the Medicine Department at the Hamad Medical Corporation, Qatar for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease. Family members of patients may be asked to participate in the study.
Who may be able to join
- Must provide informed consent
- Males and females, age 18 years and older
- Evidence of lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays and/or chest CT consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease; and (7) individuals suspected of history of lung diseased based on history and/or physical examination
- Must provide informed consent.
- Males or females ages 18 years and older.
- Non-smokers, ex-smokers and smokers.
Who cannot join
- Individual refuses consent.
- Normal control group. For the purpose of this protocol, "normal" will include individuals without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease, and will be determined by the following criteria:
- Individual refuses consent.
- Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases (Qatar)
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, COPD (chronic obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer. The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease.
Read the detailed description
This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of lung disease. The study population will include individuals with known lung diseases and controls without lung disease. Individuals in the study population will be individuals at the Hamad Medical Corporation, Qatar (HMC), as well as other individuals recruited for this study. In this protocol, researchers will survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals, and the researchers will collect blood to evaluate the genetic characteristics of individuals with chronic lung diseases including asthma, and COPD (chronic obstructive pulmonary disease), pulmonary fibrosis, and lung cancer. The researchers will also collect blood samples of individuals without lung disease to serve as control.
This protocol, to be carried out at Weill Cornell Medical College - Qatar and Hamad Medical Corporation, Qatar, parallels a similar approved protocol IRB #0508008095, entitled, "Collection of Blood for Gene Expression/Genomic Studies in Individuals with Chronic Lung Diseases", ongoing at Weill Cornell Medical College - New York.
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer
- Keywords
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer, smokers, non-smokers
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Cystic Fibrosis, Lung Neoplasms
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 |
|---|---|---|
| 1: Lung Disease | Individuals with at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-ray consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) patients with diseases of organs with known association with lung disease; and (7) individuals suspected of history of lung diseased based on history and/or physical examination | |
| 2: Normal Control | Individuals without a history of lung disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 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
- Ronald G Crystal, MD, Principal investigator, Weill Cornell Medical College, NY and Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504361
- Sponsor's protocol ID
- 0605008516
- Other IDs
- HMC RC#373/2006
- Acronym
- Q-BC
- Status last verified
- Apr 2016
- First submitted
- 19 Jul 2007
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases (Qatar)
- ClinicalTrials.gov ID
- NCT00504361
- Acronym / sponsor ID
- Q-BC / 0605008516
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer
- Keywords
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer, smokers, non-smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 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
- May 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Jul 2007 (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.
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, COPD (chronic obstructive pulmonary disease), interstitial lung disease, cystic fibrosis, and lung cancer. The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease.
Detailed description
This protocol is designed to collect a small amount of blood for extraction of DNA (genetic material) for the study of the genetic basis of lung disease. The study population will include individuals with known lung diseases and controls without lung disease. Individuals in the study population will be individuals at the Hamad Medical Corporation, Qatar (HMC), as well as other individuals recruited for this study. In this protocol, researchers will survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals, and the researchers will collect blood to evaluate the genetic characteristics of individuals with chronic lung diseases including asthma, and COPD (chronic obstructive pulmonary disease), pulmonary fibrosis, and lung cancer. The researchers will also collect blood samples of individuals without lung disease to serve as control.
This protocol, to be carried out at Weill Cornell Medical College - Qatar and Hamad Medical Corporation, Qatar, parallels a similar approved protocol IRB #0508008095, entitled, "Collection of Blood for Gene Expression/Genomic Studies in Individuals with Chronic Lung Diseases", ongoing at Weill Cornell Medical College - New York.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Lung Disease | – | –Individuals with at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-ray consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) patients with diseases of organs with known association with lung disease; and (7) individuals suspected of history of lung diseased based on history and/or physical examination |
| 2: Normal Control | – | –Individuals without a history of lung disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals visiting the Medicine Department at the Hamad Medical Corporation, Qatar for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease. Family members of patients may be asked to participate in the study.
Key inclusion criteria (6 listed)
- Must provide informed consent
- Males and females, age 18 years and older
- Evidence of lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays and/or chest CT consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease; and (7) individuals suspected of history of lung diseased based on history and/or physical examination
- Must provide informed consent.
- Males or females ages 18 years and older.
Key exclusion criteria (4 listed)
- Individual refuses consent.
- Normal control group. For the purpose of this protocol, "normal" will include individuals without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease, and will be determined by the following criteria:
- Individual refuses consent.
- Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
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
Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained.
Time frame: 5 years
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 2 May 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.
Ronald G Crystal, MD principal investigator
Weill Cornell Medical College, NY and Qatar
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 Asthma and COPD, 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 6 inclusion and 4 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 2 May 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?
Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. (time frame: 5 years). 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 2 May 2016.