Lung DiseaseQ-LDNCT00504738
Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease
An observational study of Lung Disease and Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease, Chronic Obstructive Pulmonary Disease (COPD), Asthma
- How many people
- 75 participants
- Where
- 1 siteQatar
- Study dates
- Apr 2006to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Must provide informed consent
- Males and females, age 18 years and older
- Evidence of lung disease by at least one of the following:
- symptoms consistent with pulmonary disease;
- chest X-rays and/or chest CT consistent with lung disease;
- pulmonary function tests consistent with lung disease;
Show all 11Show fewer
- lung biopsy consistent with lung disease;
- family history of lung disease;
- diseases of organs with known association with lung disease; and
- individuals suspected of having lung disease based on history and/or physical examination
- Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- lung disease, chronic obstructive pulmonary disease (COPD), asthma, smokers, non-smokers
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Ronald G. Crystal, MD, Principal investigator, Weill Cornell Medical College, New York and Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504738
- Sponsor's protocol ID
- 0604008489
- Other IDs
- HMC RC392/2006
- Acronym
- Q-LD
- Status last verified
- Apr 2015
- First submitted
- 19 Jul 2007
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lungs of Individuals With Lung Disease With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy (Qatar)
- ClinicalTrials.gov ID
- NCT00504738
- Acronym / sponsor ID
- Q-LD / 0604008489
- Keywords
- lung disease, chronic obstructive pulmonary disease (COPD), asthma, smokers, non-smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Weill Cornell Medical College in Qatar, Hamad Medical Corporation
- Study start
- Apr 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Must provide informed consent
- Males and females, age 18 years and older
- Evidence of lung disease by at least one of the following:
- Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G. Crystal, MD principal investigator
Weill Cornell Medical College, New York and Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Disease and Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.