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)

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.

Study Overview

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

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Doha, Qatar
        • Hamad Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald G Crystal, MD, Weill Cornell Medical College, NY and Qatar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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