Blood Collection From Individuals With Lung Disease for Genetic Studies (Qatar) (Q-BC)

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ClinicalTrials.gov Identifier: NCT00504361

Recruitment Status : Completed

First Posted : July 20, 2007

Last Update Posted : May 2, 2016

Sponsor:

Collaborators:

Weill Cornell Medical College in Qatar

Hamad Medical Corporation

Information provided by (Responsible Party):

Weill Medical College of Cornell University

Study Description

Brief 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. 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.

Condition or disease
Asthma COPD Interstitial Lung Disease Cystic Fibrosis Lung Cancer

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


Study Type :	Observational
Actual Enrollment :	600 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases (Qatar)
Study Start Date :	May 2006
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cystic fibrosis Lung cancer Pulmonary alveolar microlithiasis

MedlinePlus related topics: Genes and Gene Therapy Lung Diseases

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

Genomic DNA will be extracted, and genome wide SNP analysis and promoter sequences for genes will be obtained. [ Time Frame: 5 years ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

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.

Criteria

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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504361

Locations


Qatar
Hamad Medical Corporation
Doha, Qatar

Sponsors and Collaborators

Weill Medical College of Cornell University

Weill Cornell Medical College in Qatar

Hamad Medical Corporation

Investigators


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 ( Other Identifier: Hamad Medical Corporation )
First Posted:	July 20, 2007 Key Record Dates
Last Update Posted:	May 2, 2016
Last Verified:	April 2016
Individual Participant Data (IPD) Sharing Statement:
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:


Fibrosis Cystic Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes	Pancreatic Diseases Digestive System Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases

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