Clinical trial NCT00504738: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Disease
Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Keywords: lung disease
chronic obstructive pulmonary disease (COPD)
asthma
smokers
non-smokers
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Weill Cornell Medical College in Qatar
name: Hamad Medical Corporation
First posted: 2007-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Weill Cornell Medical College, New York and Qatar
name: Ronald G. Crystal, MD
role: PRINCIPAL_INVESTIGATOR
References: