Pulmonary FibrosisGPNCT00258570
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)
An observational study of Pulmonary Fibrosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purposes of this study are: to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis; to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient population includes patients who have been diagnosed with a fibrotic interstitial lung disease who have been seen by a Simmons Center Physician.
Who may be able to join
- 18 years of age or older
- Diagnosis of pulmonary fibrosis confirmed by physical examination, pulmonary function testing, chest X-ray, and computed tomography (CT) scans.
- Adult patients who are seeking treatment at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease.
Who cannot join
- Under 18 years of age
- Non-fibrotic ILD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Michelle F MacPherson, MAT, 412-647-4537, macphersonmj@upmc.edu
Michelle Meyers, BSN, 412-692-2149, meyersma@upmc.edu
About this study
Official title: Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis
The purposes of this study are:
- to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis;
- to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology that is characterized by the insidious development of lung fibrosis ultimately leading to distortion of the lung architecture, respiratory failure, and death. IPF is one of several entities associated with pulmonary fibrosis called the idiopathic interstitial pneumonias (IIP). Based on the histopathologic features of the fibrotic process, it is possible to identify four distinct entities: usual interstitial pneumonia (UIP) (synonymous with IPF), nonspecific interstitial pneumonia (NSIP), desquamative interstitial pneumonia DIP), and acute interstitial pneumonia (AIP) (Hamman-Rich lung). Each type appears to have different clinical progression and a different response to anti-inflammatory therapy. Our overall objective is to elucidate the molecular pathogenesis of IPF (UIP) by identifying factors that determine host susceptibility to this disease. We hypothesize that patients who develop pulmonary fibrosis, have a genetic propensity to abnormal lung repair that leads to fibrosis after acute lung injury. We further hypothesize that these genetic susceptibilities may determine if the pathologic process in the lung after an insult becomes UIP, AIP, NSIP, or DIP. To explore these hypotheses we propose to characterize the genetic polymorphisms in candidate genes involved in inflammation, matrix turnover, fibroblast proliferation and differentiation, and epithelial cell proliferation; and to correlate this with indices of disease progression.
- Conditions
- Pulmonary Fibrosis
- Keywords
- "Lung[A04.400]"
- Medical subject headings
- Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)
Blood samples will be collected to validate in a large cohort the per- allele associations of prespecified SNPs with IPF case status adjusted for age , sex. smoking, and principal components of ancestry.
Measured: Sample collection will occur up to 5 years based on the current rate of sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJan 2003
- Primary completionJul 2035 (estimated)
- Study completionJul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin F. Gibson, University of Pittsburgh
- Investigators
- Kevin F Gibson, MD, Principal investigator, University of Pittsburgh, Simmons Center for ILD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258570
- Sponsor's protocol ID
- STUDY20030223
- Acronym
- GP
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2005
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00258570
- Acronym / sponsor ID
- GP / STUDY20030223
- Conditions
- Pulmonary Fibrosis
- Keywords
- "Lung[A04.400]"
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jul 2035 (estimated)
- Study completion
- Jul 2035 (estimated)
- First posted
- 24 Nov 2005 (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 purposes of this study are:
- to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis;
- to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology that is characterized by the insidious development of lung fibrosis ultimately leading to distortion of the lung architecture, respiratory failure, and death. IPF is one of several entities associated with pulmonary fibrosis called the idiopathic interstitial pneumonias (IIP). Based on the histopathologic features of the fibrotic process, it is possible to identify four distinct entities: usual interstitial pneumonia (UIP) (synonymous with IPF), nonspecific interstitial pneumonia (NSIP), desquamative interstitial pneumonia DIP), and acute interstitial pneumonia (AIP) (Hamman-Rich lung). Each type appears to have different clinical progression and a different response to anti-inflammatory therapy. Our overall objective is to elucidate the molecular pathogenesis of IPF (UIP) by identifying factors that determine host susceptibility to this disease. We hypothesize that patients who develop pulmonary fibrosis, have a genetic propensity to abnormal lung repair that leads to fibrosis after acute lung injury. We further hypothesize that these genetic susceptibilities may determine if the pathologic process in the lung after an insult becomes UIP, AIP, NSIP, or DIP. To explore these hypotheses we propose to characterize the genetic polymorphisms in candidate genes involved in inflammation, matrix turnover, fibroblast proliferation and differentiation, and epithelial cell proliferation; and to correlate this with indices of disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population includes patients who have been diagnosed with a fibrotic interstitial lung disease who have been seen by a Simmons Center Physician.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Diagnosis of pulmonary fibrosis confirmed by physical examination, pulmonary function testing, chest X-ray, and computed tomography (CT) scans.
- Adult patients who are seeking treatment at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease.
Key exclusion criteria (2 listed)
- Under 18 years of age
- Non-fibrotic ILD
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
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)
Time frame: Sample collection will occur up to 5 years based on the current rate of sample collection.
Blood samples will be collected to validate in a large cohort the per- allele associations of prespecified SNPs with IPF case status adjusted for age , sex. smoking, and principal components of ancestry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- The Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease is designed to provide patient-friendly advice and support for people with idiopathic pulmonary fibrosis.Link provided by the sponsor.
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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.
Kevin F Gibson, MD principal investigator
University of Pittsburgh, Simmons Center for ILD
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 Pulmonary Fibrosis, run by University of Pittsburgh 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 3 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle F MacPherson, MAT (412-647-4537, macphersonmj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF) (time frame: Sample collection will occur up to 5 years based on the current rate of sample collection.). 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 31 Aug 2026.