Evaluation of the Lungs of Individuals With Lung Disease

NCT00224198 | Completed DMC

• 1 other identifier: 0005004440
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease; Bronchitis; Emphysema; COPD; Asthma

Outcome Measures

Primary Outcomes (1)

• Understand lung disease etiology and pathogenesis

  The primary objective is to develop and understand the etiology and pathogenesis of these lung disease disorders.

  9/31/2012

Secondary Outcomes (1)

• Identify suitable candidates

  9/31/2012

Study Arms (1)

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

Interventions

Lung Disease PROCEDURE

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.

Also known as: Bronchoscopy

Lung Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Department of Genetic Medicine, Weill Cornell Medical College

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 bronchoscopy procedure.

MeSH Terms

Conditions

Lung Diseases; Bronchitis; Emphysema; Pulmonary Disease, Chronic Obstructive; Asthma

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Ronald G Crystal, MD

  Department of Genetic Medicine, WMC of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• 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 3, 2016

Record last verified: 2016-04

Locations

US (1)