Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00320151

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

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320151

Contacts

Contact: Charleen Hollmann Dir Regulatory Affairs	646-962-2672	chollman@med.cornell.edu
Contact: Monique Licerio Research Aide	646-962-2672	mhl2002@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, MPA,RN, CCRP 646-962-2672 chollman@med.cornell.edu
Contact: Monique Licerio 626-962-2672 mhl2002@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

Responsible Party:	Weill Medical College ( Ronald G. Crystal, MD )
Study ID Numbers:	Blood Collection Protocol
Study First Received:	April 27, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00320151
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

chronic lung disease

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on January 16, 2009