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Blood Collection From Individuals With Lung Disease for Genetic Studies

This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, September 2008

Sponsors and Collaborators: Weill Medical College of Cornell University
Department of Genetic Medicine
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00362739
  Purpose

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. We 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. We aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.


Condition
Asthma
COPD
Interstitial Lung Disease
Cystic Fibrosis
Lung Cancer

Genetics Home Reference related topics:   cystic fibrosis   

MedlinePlus related topics:   Asthma    Cancer    Cystic Fibrosis    Lung Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Collection of Blood for Gene Expression/Genomic Studies in Individuals With Chronic Lung Disease

Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   Samples With DNA

Biospecimen 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.


Estimated Enrollment:   600
Study Start Date:   September 2005

Groups/Cohorts
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

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.


Criteria

Inclusion Criteria:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2)chest X-rays 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) disease of organs with know associated with lung disease; (7) individuals suspected of history of lung disease based on history and/or physical examination; and 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362739

Contacts
Contact: Charleen Hollmann, PhD, MPA, RN     646-962-2672     chollman@med.cornell.edu    
Contact: Mary Yeotsas, BA     646-962-2672     mey2003@med.cornell.edu    

Locations
United States, New York
New York Presbyterian Hospital -- Weill Cornell Mecial College of Cornell University     Recruiting
      New York, New York, United States, 10021
      Principal Investigator: Ronald G Crystal, MD            

Sponsors and Collaborators
Weill Medical College of Cornell University
Department of Genetic Medicine

Investigators
Principal Investigator:     Ronald G Crystal, MD     The New York Presbyterian Hospital -- Weill Medical College of Cornell University    
  More Information


Responsible Party:   Weill Cornell Medical College, Department of Genetic Medicine ( Dr. Ronald G. Crystal )
Study ID Numbers:   0508008095
First Received:   August 8, 2006
Last Updated:   September 15, 2008
ClinicalTrials.gov Identifier:   NCT00362739
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Thoracic Neoplasms
Lung Diseases, Interstitial
Fibrosis
Asthma
Digestive System Diseases
Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Neoplasms
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008




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