Status:
COMPLETED
Integrative-omics of the Disordered COPD Small Airway Epithelium
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Boehringer Ingelheim
Conditions:
Smoking
COPD
Eligibility:
All Genders
18-100 years
Brief Summary
We aim to use an integrated network systems approach to analyze certain existing small airway epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and me...
Detailed Description
Hypothesis: We hypothesize that the disordered differentiation of the SAE that characterizes COPD results from the complex interaction of cigarette smoke components with a hierarchy of genetic, epigen...
Eligibility Criteria
Inclusion
- Healthy nonsmokers (n=50)
- Inclusion criteria
- Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)
- Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine less than 2 ng/ml and cotinine less than 5 ng/ml)
- Negative HIV serology
- Smokers with COPD (n=50)
- Inclusion criteria
- Must be enrolled into IRB approved protocol #1204012331(all inclusion criteria from protocol #1204012331 thus applies to this protocol)
- Self-reported current daily smokers with greater than or equal to 10 pack-yr, validated by any of the following: urine nicotine greater than 30 ng/ml or urine cotinine greater than 50 ng/ml
- Meeting GOLD stages I-III criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry
- Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
- Negative HIV serology
- Healthy nonsmokers (n=50)
- Exclusion criteria
- Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)
- Evidence of malignancy within the past 5 years
- Smokers with COPD (n=50)
- Exclusion criteria
- Unable to meet the inclusion criteria (all exclusion criteria from protocol #1204012331 applies to this protocol)
- Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
- Evidence of malignancy within the past 5 years
Exclusion
Key Trial Info
Start Date :
April 6 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02183818
Start Date
April 6 2015
End Date
October 15 2020
Last Update
May 28 2021
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065