Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00320151
First received: April 27, 2006
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

This protocol is designed to gather a small amount of blood from patients seen in the New York Presbyterian Hospital-Weill Cornell Medical Center Pulmonary, Critical Care unit, and 5 West floor (Pulmonary Floor) for clinical care associated with chronic lung disease. This protocol will also survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals. Investigators aim to understand the genetics of chronic lung diseases, and will use the serum and DNA from this blood to perform various genotyping studies such as such as genomic/gene expression studies of individuals with chronic lung diseases


Condition
Pulmonary Diseases

Study Type: Observational
Official Title: Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases

Resource links provided by NLM:


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

Estimated Enrollment: 600
Study Start Date: April 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

This protocol is designed to gather a small amount of blood from patients seen in the New York Presbyterian Hospital-Weill Cornell Medical Center Pulmonary, Critical Care unit, and 5 West floor (Pulmonary Floor) for clinical care associated with chronic lung disease. This protocol will also survey medical records of patients with chronic lung disease, in order to study the clinical characteristics of these individuals. Investigators aim to understand the genetics of chronic lung diseases, and will use the serum and DNA from this blood to perform various genotyping studies such as such as genomic/gene expression studies of individuals with chronic lung diseases.

General admission criteria for this project will require 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; and (6) patients with diseases of organs with known association with lung disease.

The following studies will be conducted on blood specimens: genomic DNA will be extracted; promoter sequences for antioxidant-related genes will be obtained by PCR and sequenced. The goal is to find single nucleotide polymorphisms (SNP) to see if they correlate with lung disease. DNA samples and blood specimens will be coded. Samples could potentially be traced back to the patient. However, every effort will be made to keep the patient's identity confidential per HIPAA regulations.

The study does not aim to create a blood bank. Rather, the blood samples will be used for DNA extraction only. Serum will be stored for future studies, to look at levels of proteins.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General admission criteria for this project will require 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; and (6) patients with diseases of organs with known association with 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; and (6) diseases of organs with known association with lung disease

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: NCT00320151

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

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
New York City, New York, United States, 10021
Contact: Charleen Hollmann, PhD    646-962-2672    chollman@med.cornell.edu   
Contact: Katrina Bandong, BA    646-962-2672    kab2036@med.cornell.edu   
Principal Investigator: Ronald G Crystal, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ronald G. Crystal, M.D. Weill Medical College of Cornell University
Study Director: Ben-Gary Harvey, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00320151     History of Changes
Other Study ID Numbers: Blood Collection Protocol
Study First Received: April 27, 2006
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
chronic lung disease

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014