Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar) (Q-BC)
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Purpose
| Condition |
|---|
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Asthma COPD Interstitial Lung Disease Cystic Fibrosis Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases (Qatar) |
- Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
| Enrollment: | 600 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00504361
| Qatar | |
| Hamad Medical Corporation | |
| Doha, Qatar | |
| Principal Investigator: | Ronald G Crystal, MD | Weill Cornell Medical College, NY and Qatar |
More Information
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00504361 History of Changes |
| Other Study ID Numbers: | 0605008516 HMC RC#373/2006 |
| Study First Received: | July 19, 2007 |
| Last Updated: | April 29, 2016 |
| Health Authority: | United States: Institutional Review Board Qatar: Hamad Medical Corporation |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Keywords provided by Weill Medical College of Cornell University:
|
Asthma COPD Interstitial Lung Disease Cystic Fibrosis |
Lung Cancer smokers non-smokers |
Additional relevant MeSH terms:
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Lung Neoplasms Fibrosis Cystic Fibrosis Lung Diseases Lung Diseases, Interstitial Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Respiratory Tract Diseases Pathologic Processes Pancreatic Diseases Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on September 28, 2016