Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224198
Status:
COMPLETED
Last Update Posted:
2016-05-03
First Post:
2005-09-20
Brief Title:
Evaluation of the Lungs of Individuals With Lung Disease
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Evaluation of the Lungs of Individuals With Lung Disease With Segmental Bronchopulmonary Lung Lavage Bronchial Brushing and Bronchial Wall Biopsy
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this protocol is to obtain biologic materials from the blood and lungs from patients with lung disease in order to develop an understanding of the etiology and pathogenesis of these disorders General admission criteria for this project will require at least one of the following 1 symptoms consistent with pulmonary disease 2 chest X-ray consistent with lung disease 3 pulmonary function tests consistent with lung disease 4 lung biopsy consistent with lung disease 5 family history of lung disease and 6 patients with diseases of organs with known association with lung disease
Detailed Description:
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 andor 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 andor bronchoalveolar lavage andor bronchial wall biopsy The primary factor for determining if an individual will have bronchial alveolar lavages BAL andor brushings andor 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 individuals tolerance to the procedure
The study individual will undergo fiberoptic bronchoscopy with a combination of bronchial brushing andor bronchoalveolar lavage andor bronchial wall biopsy The primary factor for determining if an individual will have bronchial alveolar lavages BAL andor brushings andor 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 individuals tolerance to the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None