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Evaluation of the Lungs of Individuals With Lung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00224198
First received: September 20, 2005
Last updated: April 29, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Lung Disease
Bronchitis
Emphysema
COPD
Asthma
Procedure: Lung Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Specimens will be retained from both a blood draw and a bronchoscopy procedure.

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)
Groups/Cohorts Assigned Interventions
Lung Disease
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The source of potential subjects will be the population of individuals 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.
Criteria

Inclusion Criteria:

  • Must provide informed consent
  • Males and females, age 18 years and older
  • Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays 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) diseases of organs with known association with lung disease
  • Must provide HIV informed consent

Exclusion Criteria:

  • Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study
  • Drug and/or alcohol abuse within the past six months
  • Females who are pregnant or nursing
  • Individuals who test positive for HIV (other than for studies directly related to the HIV virus)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224198

Locations
United States, New York
Department of Genetic Medicine, Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ronald G Crystal, MD Department of Genetic Medicine, WMC of Cornell University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00224198     History of Changes
Other Study ID Numbers: 0005004440
Study First Received: September 20, 2005
Last Updated: April 29, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lung Diseases
Emphysema
Bronchitis
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Respiratory Tract Infections

ClinicalTrials.gov processed this record on March 24, 2017