Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar) (Q-BC)
|First Received Date ICMJE||July 19, 2007|
|Last Updated Date||December 19, 2013|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00504361 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar)|
|Official Title ICMJE||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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
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. Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. The goal is to find single nucleotide polymorphims (SNP), small changes in single genes that affect disease risk, to see if they correlate with lung disease.
|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.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||600|
|Completion Date||May 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Lung Disease group. Individuals with lung disease who fit the following criteria will be enrolled.
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:
|Ages||18 Years to 90 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Qatar|
|Removed Location Countries|
|NCT Number ICMJE||NCT00504361|
|Other Study ID Numbers ICMJE||0605008516, HMC RC#373/2006|
|Has Data Monitoring Committee||No|
|Responsible Party||Weill Medical College of Cornell University|
|Study Sponsor ICMJE||Weill Medical College of Cornell University|
|Information Provided By||Weill Medical College of Cornell University|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP