The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers i… (NCT00974064) | Clinical Trial Compass
CompletedNot Applicable
The Natural History of Gene Expression in the Lung Cells of Non-Smokers, Smokers and Ex-Smokers in Health and Disease
United States171 participantsStarted 2009-08
Plain-language 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 COPD suggesting that genetic factors affect the lung's susceptibility to the stress of cigarette smoke. The cells lining the airways (epithelium) and cells that help defend the lung (alveolar macrophages) of smokers develop gene expression changes that are different from that of nonsmokers. In the investigators' previous studies they have demonstrated that there are greater than 200 genes that are responsive to cigarette smoke in these cells. But the investigators do not know whether the gene expression is static or changes as a function of time. Genes that show significant changes over time may be relevant to the progression of the disease. Even though quitting smoking reduces the rate at which the lungs decline, many-smokers still go on to develop COPD. This study will provide insights into the natural history of smoking-related gene expression of the lung cells in health and disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate gene expression over time
Timeframe: 12/31/2013
Trial details
NCT IDNCT00974064
SponsorWeill Medical College of Cornell University