Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy
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Purpose
The purpose of this study is to obtain biologic materials from the blood and lungs of normal individuals to establish a set of normal range for various parameters. These will provide important information when applied to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases.
| Condition | Intervention |
|---|---|
|
Smoking Lung Diseases |
Procedure: Bronchopulmonary Lung Lavage Procedure: Bronchial Brushing Procedure: Bronchial Wall Biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of the Lungs of Normal Individuals With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy |
- Evaluate etiology of lung diseases [ Time Frame: 9/31/2012 ] [ Designated as safety issue: No ]We hope to learn more about the specific causes of lung disease, how lung disease manifests and progresses, and how lung disease can be treated.
- Effect of smoking on the genes of airway epithelial cells [ Time Frame: 9/31/2012 ] [ Designated as safety issue: No ]We hope to learn how smoking affects the genetic composition of the cells that line the airways (windpipes) of the lungs, and whether there are differences in the genetic composition of the cells that line the windpipe in normal individuals who smoke.
Biospecimen Retention: Samples With DNA
Specimens will be retained from both a blood draw and a bronchial wall biopsy which obtains tissue to a depth of 2-3 mm and includes epithelial and subepithelial tissue.
| Enrollment: | 196 |
| Study Start Date: | January 2004 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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Procedure: Bronchopulmonary Lung Lavage
Study procedures will be performed at the Weill Cornell Medical College-New York Presbyterian Hospital and/or Weill Greenburg York Avenue Building. Study procedures done elsewhere that are within the protocol timeframe will be accepted if seen fit by the investigators so that they are not repeated unnecessarily. Study individuals who undergo bronchoscopy with intravenous administration of sedatives and analgesia may be required to stay overnight. Bronchoscopy is normally an ambulatory procedure. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. An overnight stay would only be required if the individual was not, in the judgment of the attending physician, safe to be discharged as is standard practice. Follow up of all participants are carried out by telephone within 1 wk following the procedure.
Rockefeller University has been added as a second site.
Individuals undergoing bronchoscopy without intravenous administration of sedatives and analgesia are not required to stay overnight due to the lack of administration of CNS-altering drugs and the limited sampling involved (tracheal brushes only).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The source of potential subjects will be the population of 'normal', as defined by the eligibility criteria below, individuals in the New York metropolitan area and elsewhere. Up to one hundred volunteers will take part in the study each year. Accrual will be random with no bias as to gender or racial/ethnic group. All study individuals will be males or females that are 18 years or older and are able to provide informed consent. Advertisements will be posted at various educational institutions and hospitals and placed in newspapers in the New York metropolitan area. Paid volunteer referrals will also be used for patient recruitment.
Inclusion Criteria:
- All study subjects should be able to provide informed consent
- Males or females ages 18 years and older.
- Must provide HIV informed consent.
- Non-smokers, ex-smokers and smokers.
Exclusion Criteria:
- Individuals not deemed in good overall health by the investigator will not be accepted into the study.
- Drug and/or alcohol abuse within the past six months.
- Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
- Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
- Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study
- Females who are pregnant or nursing will not be accepted into the study
Contacts and Locations| United States, New York | |
| Department of Genetic Medicine, WMC of Cornell Univeristy | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Ronald G Crystal, MD | Department of Genetic Medicine, Weill Cornell Medical College |
More Information
No publications provided by Weill Medical College of Cornell University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00224185 History of Changes |
| Obsolete Identifiers: | NCT00234325 |
| Other Study ID Numbers: | IRB0005004439 |
| Study First Received: | September 20, 2005 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
|
Healthy individuals smokers ex-smokers non-smokers |
Additional relevant MeSH terms:
|
Lung Diseases Smoking Respiratory Tract Diseases Habits |
ClinicalTrials.gov processed this record on May 23, 2013