Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy

NCT00224185 | Completed DMC

• 1 other identifier: IRB0005004439
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking; Lung Diseases

Keywords

Healthy individuals; smokers; ex-smokers; non-smokers

Outcome Measures

Primary Outcomes (1)

• Evaluate etiology of lung diseases

  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.

  9/31/2012

Secondary Outcomes (1)

• Effect of smoking on the genes of airway epithelial cells

  9/31/2012

Interventions

Bronchopulmonary Lung Lavage PROCEDURE

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.

Also known as: Bronchoalveolar Lavage

Bronchial Brushing PROCEDURE

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.

Also known as: Bronchial Washing

Bronchial Wall Biopsy PROCEDURE

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.

Also known as: Lung Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York Presbyterian Hospital: collaborator
• Rockefeller University: collaborator

Study Sites (1)

Department of Genetic Medicine, WMC of Cornell Univeristy

New York, New York, 10021, United States

Location

Related Publications (2)

• Wang G, Wang R, Ferris B, Salit J, Strulovici-Barel Y, Hackett NR, Crystal RG. Smoking-mediated up-regulation of GAD67 expression in the human airway epithelium. Respir Res. 2010 Oct 29;11(1):150. doi: 10.1186/1465-9921-11-150.

  PMID: 21034448 DERIVED

• Carolan BJ, Harvey BG, Hackett NR, O'Connor TP, Cassano PA, Crystal RG. Disparate oxidant gene expression of airway epithelium compared to alveolar macrophages in smokers. Respir Res. 2009 Nov 17;10(1):111. doi: 10.1186/1465-9921-10-111.

  PMID: 19919714 DERIVED

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.

MeSH Terms

Conditions

Smoking; Lung Diseases; Smoking Cessation

Interventions

Bronchoalveolar Lavage; Bronchoalveolar Lavage Fluid

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Diseases; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Ronald G Crystal, MD

  Department of Genetic Medicine, Weill Cornell Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2004
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)