Evaluation of the Lungs of Individuals With Lung Disease
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Evaluation of the Lungs of Individuals With Lung Disease With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy|
- Understand lung disease etiology and pathogenesis [ Time Frame: 9/31/2012 ]The primary objective is to develop and understand the etiology and pathogenesis of these lung disease disorders.
- Identify suitable candidates [ Time Frame: 9/31/2012 ]The secondary objective is to identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2004|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
All study individuals will be males or females that are 18 years or older and are able to provide informed consent and have been diagnosed with lung disease.
Procedure: Lung Disease
Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. In 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.In the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently to obtain epithelial cells lining the airway. Certain individuals may have bronchial wall biopsy carried out. In this procedure, a small biopsy forceps is passed through the bronchoscope and a small biopsy is obtained from the bronchial wall.
Other Name: Bronchoscopy
Patients will undergo a general medical evaluation by a pulmonary physician (and consultants as appropriate for other organs). The typical routine medical studies to be carried out may include: chest X-ray (posterior-anterior and lateral), non-contrast high resolution CT scan of the chest, pulmonary function tests, electrocardiogram, echocardiogram, general hematologic studies, general serologic studies, /immunologic studies, biochemical analyses (including carboxyhemoglobin to measure blood carbon monoxide levels in order to accurately evaluate the diffusion capacity in individuals who smoke since smoking increases the blood levels of carbon monoxide), alcohol blood test, urinalysis, urine chemistries (including blood or urine nicotine and cotinine test to evaluate urine for active or passive exposure to nicotine), blood or urine drug screening (to evaluate use of recreational drugs and/or mood altering medications), pregnancy test (if applicable) and HIV serology. Also, a sweat chloride and sweat rate test may be performed by the physician to evaluate participants with a possible diagnosis of cystic fibrosis.
The study individual will undergo fiberoptic bronchoscopy with a combination of bronchial brushing and/or bronchoalveolar lavage and/or bronchial wall biopsy. The primary factor for determining if an individual will have bronchial alveolar lavages (BAL) and/or brushings and/or biopsies is the particular lung disease affecting the individual. This will depend on the known mechanism relevant to the pathogenesis of the particular disease. For example, in individuals with asthma, the samples may include airway brushing and airway biopsies; in contrast, in individuals with chronic obstructive pulmonary disease (COPD), sampling may include airway brushings, airway biopsies, and bronchoalveolar lavage. Other determining factors include: the amount of moderate sedation (if used) and the amount of analgesia used; the maximal dosage of topical lidocaine that is allowed per procedure; allergic reactions to any of the medications used in the procedures; and individual's tolerance to the procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224198
|United States, New York|
|Department of Genetic Medicine, Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Ronald G Crystal, MD||Department of Genetic Medicine, WMC of Cornell University|