Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 19, 2007

Last Updated Date

September 15, 2008

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00504738 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease

Official Title ^†

Evaluation of the Lungs of Individuals With Lung Disease With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy (Qatar)

Brief Summary

The purpose of this protocol is to obtain biologic samples from the blood and lungs from patients with lung diseases in order to study the causes and indications of these disorders, learn how these lung disease manifest and progress, and how the lung disease can be treated.

Detailed Description

The lung diseases are disorders associated with functional and/or structural derangements to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this protocol is to obtain biologic materials from the blood and lungs from these patients in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs. As such, this protocol is part of the "infrastructure" for all of our human lung-related studies such as genomic/gene expression studies of airway epithelium and alveolar macrophages in all individuals with chronic obstructive lung disease (COPD), asthma, bronchogenic carcinoma, and pulmonary fibrosis compared to normal non-smokers and smokers, and studies of mediators in bronchoalveolar lavage fluid.

This protocol, to be carried out at Weill Cornell Medical College - Qatar and Hamad Medical Corporation, Qatar, parallels a similar approved protocol IRB

0005004440, entitled, "Evaluation of the Lungs of Individuals with Lung Disease with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", ongoing at Weill Cornell Medical College - New York.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Lung Disease
Chronic Obstructive Pulmonary Disease (COPD)
Asthma

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

200

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Inclusion/Exclusion criteria for Part A

Must provide informed consent
Males and females, age 18 years and older
Evidence of lung disease by at least one of the following:
1. symptoms consistent with pulmonary disease;
2. chest X-rays and/or chest CT 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;
6. diseases of organs with known association with lung disease; and
7. individuals suspected of having lung disease based on history and/or physical examination
Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care

Exclusion Criteria:

Patient refuses consent.

Patients enrolled in Part A of the protocol will not undergo screening procedures/tests. These patients are undergoing a fiberoptic bronchoscopy as dictated by their standard clinical care and additional samples will be taken for research purposes.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Charleen Hollmann, PhD, RN	646-962-2672	chollman@med.cornell.edu
Contact: Mary Yeotsas, BA	646-962-2672	mey2003@med.cornell.edu

Location Countries ^†

Qatar

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00504738

Responsible Party

Dr. Ronald G. Crystal, Weill Cornell Medical College, Department of Genetic Medicine

Secondary IDs ^††

HMC RC392/2006

Study Sponsor ^†

Weill Medical College of Cornell University

Collaborators ^††

Weill Cornell Medical College in Qatar
Hamad Medical Corporation

Investigators ^†

Principal Investigator:

Ronald G. Crystal, MD

Weill Cornell Medical College, New York and Qatar

Information Provided By

Weill Medical College of Cornell University

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.