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Blood Collection From Individuals With Lung Disease for Genetic Studies

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ClinicalTrials.gov Identifier: NCT00362739
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

August 8, 2006
August 10, 2006
April 29, 2016
September 2005
August 2015   (Final data collection date for primary outcome measure)
Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity. [ Time Frame: 5 years ]
Not Provided
Complete list of historical versions of study NCT00362739 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Blood Collection From Individuals With Lung Disease for Genetic Studies
Collection of Blood for Gene Expression/Genomic Studies in Individuals With Chronic Lung Disease
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), 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. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
In this study, a small amount of blood for extraction of DNA for the study of the genetic basis of lung disease will be obtained from each subject. The collected blood (cells and serum) will be used for genetic testing in studies relating to the genetic material and/or gene expression, and/or studies of proteins or other substances in serum (the liquid portion of the blood after it has been allowed to clot). Because these latter protein studies will occur at a future date, the serum will be stored for use in these studies.
Non-Probability Sample
Individuals visiting the Starr-5 Pulmonary, Critical Care Unit, and 5 West floor for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease.
  • Asthma
  • COPD
  • Interstitial Lung Disease
  • Cystic Fibrosis
  • Lung Cancer
Not Provided
  • 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; (7) individuals suspected of history of lung diseased based on history and/or physical examination
  • 2: Normal Controls
    Individuals without a history of lung disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3087
600
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Lung disease proven by at least one of the following:

    • symptoms consistent with pulmonary disease
    • chest X-rays consistent with lung disease
    • pulmonary function tests consistent with lung disease
    • lung biopsy consistent with lung disease
    • family history of lung disease
    • disease of organs with know associated with lung disease
    • individuals suspected of history of lung disease based on history and/or physical examination
    • normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.

Exclusion Criteria:

  • Drug and/or alcohol abuse within the past six months
  • Females who are pregnant or nursing
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00362739
0508008095
Yes
Not Provided
Plan to Share IPD: Undecided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Ronald G Crystal, MD The New York Presbyterian Hospital -- Weill Medical College of Cornell University
Weill Medical College of Cornell University
April 2016