Blood Collection From Individuals With Lung Disease for Genetic Studies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00362739
First received: August 8, 2006
Last updated: April 28, 2016
Last verified: April 2016
  Purpose
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.

Condition
Asthma
COPD
Interstitial Lung Disease
Cystic Fibrosis
Lung Cancer

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
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.

Enrollment: 3087
Study Start Date: September 2005
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
New York Presbyterian Hospital -- Weill Cornell Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ronald G Crystal, MD The New York Presbyterian Hospital -- Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00362739     History of Changes
Other Study ID Numbers: 0508008095 
Study First Received: August 8, 2006
Last Updated: April 28, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cystic Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 25, 2016