Idiopathic Pulmonary FibrosisNCT00453713
Race, Ethnicity, and Diffuse Parenchymal Lung Disease
An observational study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to identify factors that contribute to higher mortality rates among blacks and Hispanics with diffuse parenchymal lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Diffuse Parenchymal Lung Disease
- How many people
- 565 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2013
- 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: Diffuse parenchymal lung disease
Who may be able to join
- Diagnosis of IPF or other DPLD according to ATS criteria
- Signed informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Determinants of Outcome in Diffuse Parenchymal Lung Disease
The purpose of this study is to identify factors that contribute to higher mortality rates among blacks and Hispanics with diffuse parenchymal lung disease.
Read the detailed description
It is well known that both socioeconomic and biological factors may contribute to race- and ethnicity-based health disparities. Black and Hispanic Americans have worse access to healthcare services and tend to receive care from physicians who cannot themselves access the same services for their patients that physicians who care for white patients can. These factors may play important roles in the development and maintenance of health disparities. In addition, biological differences may contribute to disparities. We propose to identify factors that explain survival disparities in a group of lung diseases called diffuse parenchymal lung diseases (DPLDs), including a severe form of DPLD called idiopathic pulmonary fibrosis (IPF). We will follow patients with DPLD at our center and measure both social and biological factors to try to identify the factors that lead to survival disparities between races. Results of this study will be used to design clinical trials aimed at reducing these disparities.
- Conditions
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Diffuse Parenchymal Lung Disease
- Keywords
- Idiopathic pulmonary fibrosis, Interstitial lung disease, Diffuse parenchymal lung disease, Health disparities
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJul 2006
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David J. Lederer, M.D., Columbia University
- Investigators
- David J Lederer, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453713
- Sponsor's protocol ID
- AAAB8771
- Other IDs
- K23HL086714
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2007
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Determinants of Outcome in Diffuse Parenchymal Lung Disease
- ClinicalTrials.gov ID
- NCT00453713
- Acronym / sponsor ID
- AAAB8771
- Conditions
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Diffuse Parenchymal Lung Disease
- Keywords
- Idiopathic pulmonary fibrosis, Interstitial lung disease, Diffuse parenchymal lung disease, Health disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2006
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Mar 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 study is to identify factors that contribute to higher mortality rates among blacks and Hispanics with diffuse parenchymal lung disease.
Detailed description
It is well known that both socioeconomic and biological factors may contribute to race- and ethnicity-based health disparities. Black and Hispanic Americans have worse access to healthcare services and tend to receive care from physicians who cannot themselves access the same services for their patients that physicians who care for white patients can. These factors may play important roles in the development and maintenance of health disparities. In addition, biological differences may contribute to disparities. We propose to identify factors that explain survival disparities in a group of lung diseases called diffuse parenchymal lung diseases (DPLDs), including a severe form of DPLD called idiopathic pulmonary fibrosis (IPF). We will follow patients with DPLD at our center and measure both social and biological factors to try to identify the factors that lead to survival disparities between races. Results of this study will be used to design clinical trials aimed at reducing these disparities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diffuse parenchymal lung disease
Key inclusion criteria (2 listed)
- Diagnosis of IPF or other DPLD according to ATS criteria
- Signed informed consent
Key exclusion criteria (1 listed)
- None
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.
David J Lederer, M.D. principal investigator
Columbia 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 Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by Columbia 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 2 inclusion and 1 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 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.
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.