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

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

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Doha, Qatar
        • Hamad Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruitment will be from the patients of the Hamad Medical Corporation and others as relevant. The source of potential subjects will be the population of potential subjects with lung disease, as defined by the elegibility criteria, in Qatar. Accrual will be random with no bias as to gender or racial/ethnic group.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronald G. Crystal, MD, Weill Cornell Medical College, New York and Qatar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0604008489
  • HMC RC392/2006 (Other Identifier: Hamad Medical Corporation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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