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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00504738
Other study ID # 0604008489
Secondary ID HMC RC392/2006
Status Completed
Phase N/A
First received July 19, 2007
Last updated April 20, 2015
Start date April 2006
Est. completion date April 2007

Study information

Verified date April 2015
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardQatar: Hamad Medical Corporation
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Qatar Hamad Medical Corporation Doha

Sponsors (3)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Hamad Medical Corporation, Weill Cornell Medical College in Qatar

Country where clinical trial is conducted

Qatar, 

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