Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy
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|ClinicalTrials.gov Identifier: NCT00224185|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment|
|Smoking Lung Diseases||Procedure: Bronchopulmonary Lung Lavage Procedure: Bronchial Brushing Procedure: Bronchial Wall Biopsy|
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).
|Study Type :||Observational|
|Actual Enrollment :||196 participants|
|Official Title:||Evaluation of the Lungs of Normal Individuals With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- Procedure: Bronchopulmonary Lung Lavage
Lung Lavage is a Washing. Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways. Once the fluid has been collected, the fluid is centrifuged and the cells are collected and counted.Other Name: Bronchoalveolar Lavage
- Procedure: Bronchial Brushing
Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently (in up to 20 different sites in the large and small airways) to obtain epithelial cells lining the airway. Cells collected by airway brushing will be washed, counted, and evaluated for viability. They will also be studied for differential cell count by standard procedures. Collected airway cells will be used to carry out studies assess expression of various genes and to study viral gene transfer.Other Name: Bronchial Washing
- Procedure: Bronchial Wall Biopsy
This is a safe and widely used investigative method in pulmonary medicine. In this procedure, a small biopsy forceps is passed through the bronchoscope and, under direct vision, a small biopsy (in up to 5 sites) is obtained from the bronchial wall. A biopsy obtains tissue to a depth of 2-3 mm, and includes epithelial and subepithelial tissue.Other Name: Lung Biopsy
- Evaluate etiology of lung diseases [ Time Frame: 9/31/2012 ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224185
|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|