- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00320151
Collection of Blood for Gene Expression Study in Individuals With Chronic Lung Diseases
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Study Director: Ben-Gary Harvey, M.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Blood Collection Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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