AsthmaNCT00362739
Blood Collection From Individuals With Lung Disease for Genetic Studies
An observational study of Asthma and COPD, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Interstitial Lung Disease
- How many people
- 3,087 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals visiting the Starr-5 Pulmonary, Critical Care Unit, and 5 West floor for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease.
Who may be able to join
- Must provide informed consent
- Males and females, age 18 years and older
- Lung disease proven by at least one of the following:
- symptoms consistent with pulmonary disease
- chest X-rays 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
- disease of organs with know associated with lung disease
- individuals suspected of history of lung disease based on history and/or physical examination
- normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.
Who cannot join
- Drug and/or alcohol abuse within the past six months
- Females who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital -- Weill Cornell Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Collection of Blood for Gene Expression/Genomic Studies in Individuals With Chronic Lung Disease
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.
Read the detailed description
The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Cystic Fibrosis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1: Lung Disease | Individuals with at least one of the following: (1)symptoms consistent with pulmonary disease; (2) chest X-ray 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) patients with diseases of organs with known association with lung disease; (7) individuals suspected of history of lung diseased based on history and/or physical examination | |
| 2: Normal Controls | Individuals without a history of lung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startSep 2005
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald G Crystal, MD, Principal investigator, The New York Presbyterian Hospital -- Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362739
- Sponsor's protocol ID
- 0508008095
- Status last verified
- Apr 2016
- First submitted
- 8 Aug 2006
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood for Gene Expression/Genomic Studies in Individuals With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00362739
- Acronym / sponsor ID
- 0508008095
- Conditions
- Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Aug 2006 (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.
This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.
Detailed description
The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Lung Disease | – | –Individuals with at least one of the following: (1)symptoms consistent with pulmonary disease; (2) chest X-ray 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) patients with diseases of organs with known association with lung disease; (7) individuals suspected of history of lung diseased based on history and/or physical examination |
| 2: Normal Controls | – | –Individuals without a history of lung disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals visiting the Starr-5 Pulmonary, Critical Care Unit, and 5 West floor for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease.
Key inclusion criteria (11 listed)
- Must provide informed consent
- Males and females, age 18 years and older
- Lung disease proven by at least one of the following:
Key exclusion criteria (2 listed)
- Drug and/or alcohol abuse within the past six months
- Females who are pregnant or nursing
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
Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity.
Time frame: 5 years
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 29 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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
The New York Presbyterian Hospital -- Weill Medical College of Cornell University
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 Asthma and COPD, run by Weill Medical College of Cornell University at 1 site in United States.
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 29 Apr 2016. 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 United States. 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.
What does the primary outcome measure?
Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity. (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 29 Apr 2016.