Status:
COMPLETED
The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers in Health and Disease
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Smoking
Eligibility:
All Genders
18+ years
Brief Summary
Cigarette smoking is the major risk factor for chronic obstructive pulmonary disease (COPD, commonly known as chronic bronchitis and emphysema). Despite this clear link, only 15-20% of smokers develop...
Detailed Description
Cigarette smoke is responsible for the majority of lung cancers and is the major cause of COPD, the fourth leading cause of death in the United States. Despite the well established causal role of ciga...
Eligibility Criteria
Inclusion
- Group A: Healthy nonsmokers
- All study individuals should be enrolled in the "Airway" protocol #1204012331 "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies"
- Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies
- Male and Female subject ≥18 years of age
- Never smokers is defined as someone who has smoked \< 100 cigarettes per lifetime and whose urine nicotine \<2 ng/mL and/or urine cotinine \<5 ng/mL, at entry into the study
- Group B: Healthy current smokers Inclusion:
- All study individuals should be enrolled in the "Airway" protocol
- Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies
- Male and Female subject ≥18 years of age
- Active smoker as evidenced by self-report and urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/mL
- Group C: Healthy smokers who elect to stop smoking Inclusion:
- All study individuals should be enrolled in the "Airway" protocol
- Willing and able to provide informed consent for the long term follow up study with repeated bronchoscopies
- Male and Female subject ≥18 years of age
- Current smoker as evidenced by self-report and urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/mL
- Be a current smoker willing to stop smoking
- Group D - Current smokers with COPD Inclusion:
- All study subjects will be enrolled in the "Airway" protocol #1204012331 "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies"
- All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure
- All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies
- Male and Female subject ≥18 years of age
- Active smokers as evidenced by urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/mL
- Group E - Current smokers with COPD who elect to stop smoking Inclusion:
- All study subjects will be enrolled in the "Airway" protocol #1204012331 "Collection of Airway, Blood and/or Urine Specimens from Subjects for Research Studies"
- All study subjects should meet the lung disease criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure
- All study subjects should be able to provide informed consent for the long term follow up study with repeated bronchoscopies
- Male and Female subject ≥18 years of age
- Active smokers as evidenced by urine nicotine \>30 ng/mL and/or urine cotinine \>50 ng/mL
- Be a current smoker willing to stop smoking
Exclusion
- Groups A - E
- Individuals unable to provide proper informed consent
- Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
- Individuals with asthma and with recurrent or recent (within three months) and/or acute pulmonary infection
- Individuals with allergy to lidocaine
- Significant kidney disease or subjects on dialysis
- Females who are pregnant or lactating or intending to become pregnant in the next 12 months
- Subjects who are HIV positive
- Subjects that have unstable coronary artery disease as evidenced by unstable angina, \>Class II New York Heart Association (NYHA) cardiac status, history of congestive heart failure or MI within the last 12 months
- Subjects who are contraindicated for undergoing bronchoscopy
- Subjects having any medical condition that in the opinion of the investigator would preclude the subject from entering the study
- Groups D and E
- \- Subjects may not have evidence of respiratory failure such as SpO2 \<90% or PaO2 \<60 mmHg
- Groups C and E
- Current major depression or other significant psychiatric disorder
- Subjects currently taking anti-depressant medication
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00974064
Start Date
August 1 2009
End Date
June 1 2013
Last Update
July 27 2020
Active Locations (1)
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1
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, United States, 10065-4870