- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504361
Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar) (Q-BC)
Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases (Qatar)
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Doha, Qatar
- Hamad Medical Corporation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Lung Disease group. Individuals with lung disease who fit the following criteria will be enrolled.
Inclusion criteria
- 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
Exclusion criteria
- 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:
Inclusion Criteria:
- Must provide informed consent.
- Males or females ages 18 years and older.
- Non-smokers, ex-smokers and smokers.
Exclusion 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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2: Normal Control
Individuals without a history of lung disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained.
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Ronald G Crystal, MD, Weill Cornell Medical College, NY and Qatar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0605008516
- HMC RC#373/2006 (Other Identifier: Hamad Medical Corporation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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