The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers in Health and Disease
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|ClinicalTrials.gov Identifier: NCT00974064|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2009
Last Update Posted : May 1, 2018
|Condition or disease|
|Chronic Obstructive Pulmonary Disease (COPD) Smoking Smoking Cessation Chronic Bronchitis Emphysema|
|Study Type :||Observational|
|Estimated Enrollment :||210 participants|
|Official Title:||The Natural History of Gene Expression in Lung Cells of Non-Smokers, Smokers, and Ex-Smokers in Health and Disease|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
A-Healthy Non smokers
Healthy nonsmokers. Defined as non-smokers by self report and urine cotinine levels consistent with a nonsmoker (urine cotinine <5 ng/mL).
Healthy current smokers. Subjects categorized as healthy according to criteria under "Collection" (#1204012331) protocol.
C-Healthy smoker to quit
Healthy smokers willing to quit. Defined by self-report and urine cotinine levels consistent with an active smoker (urine cotinine >50 ng/mL).
D-Current smoker w. COPD
Current smokers with COPD. COPD as defined by the GOLD criteria and currently smoking as defined by self-report and urine cotinine levels consistent with an active smoker (urine cotinine >50 ng/mL)
E-Current COPD smoker to quit
Current smokers with COPD willing to stop smoking. Subjects have COPD as defined by the GOLD criteria
- Evaluate gene expression over time [ Time Frame: 12/31/2013 ]To prospectively assess changes in lung cell gene expression over time in healthy nonsmokers, healthy smokers and smokers with COPD. To examine what smoking-induced gene expression changes occur in the lung cells of healthy smokers and COPD smokers over time in response to cessation of smoking.
- Quitters who return to smoking and the effects on gene expression [ Time Frame: 12/31/2012 ]In individuals who quit but start smoking again despite the standard smoking cessation therapy, what are the effects on gene expression of returning to smoking. To assess whether baseline gene expression determines what genes rapidly change to a more "normal" expression pattern with smoking cessation. Does having established COPD determine the relative reversibility of the gene expression pattern with smoking cessation compared to healthy smokers.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974064
|United States, New York|
|Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine|
|New York, New York, United States, 10065-4870|
|Principal Investigator:||Ronald G. Crystal, M.D.||Weill Medical College of Cornell University|