Idiopathic Pulmonary FibrosisGAPNCT00373841
Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis (IPF)
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2030
- 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: Patients aged 18 and older who have been diagnosed with IPF and referred by a Simmons Center doctor.
Who may be able to join
- Patients who are 18 or older
- Diagnosis of Idiopathic Pulmonary Fibrosis
- Treated at the Simmons Center
Who cannot join
- Other Lung Illness
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
Michelle F MacPherson
Pittsburgh, Pennsylvania, 15213
Michelle F MacPherson, MAT, 14126474537, macphersonmj@upmc.edu
Michelle L Meyers, BSN RN, 412-692-2149, meyersma@upmc.edu
About this study
Official title: Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis
The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.
Read the detailed description
People who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. The subject must be treated at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Subjects, if consented, are required to perform tests so that research data can be collected. At the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and CT scans as well as completing several questionnaires designed to measure how the patient is feeling. Follow up visits are then scheduled in 3-4 month intervals. Every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. If the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. All of the results of clinical and laboratory testing will be placed into the subjects research file.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Lung, Fibrosis, Idiopathic, Biomarkers, Genomics, Longitudinal
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- 500 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 - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373841
- Sponsor's protocol ID
- STUDY19040326
- Acronym
- GAP
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2006
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.
PubMed 24177001
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00373841
- Acronym / sponsor ID
- GAP / STUDY19040326
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Lung, Fibrosis, Idiopathic, Biomarkers, Genomics, Longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 8 Sep 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.
The purpose of the study is to identify genetic and biologic markers that may predict the loss of lung function due to idiopathic pulmonary fibrosis. The studies will compare genetic and biologic markers of samples to changes in symptoms. The ultimate goal is to predict if or when patients are likely to experience a rapid decline in lung function due to disease progression.
Detailed description
People who are diagnosed with idiopathic pulmonary fibrosis are asked to participate in this study. The subject must be treated at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Subjects, if consented, are required to perform tests so that research data can be collected. At the initial visit, patients are subject to having a blood draw, pulmonary function testing, echocardiograms, and CT scans as well as completing several questionnaires designed to measure how the patient is feeling. Follow up visits are then scheduled in 3-4 month intervals. Every 3-4 months blood samples will be collected while every 6-8 months the questionnaires will administered. If the patient enters a stage of accelerated decline in lung function, a bronchoscopy will be performed to collect residual bronchoalveolar lavage fluid for testing. All of the results of clinical and laboratory testing will be placed into the subjects research file.
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
- Patients aged 18 and older who have been diagnosed with IPF and referred by a Simmons Center doctor.
Key inclusion criteria (3 listed)
- Patients who are 18 or older
- Diagnosis of Idiopathic Pulmonary Fibrosis
- Treated at the Simmons Center
Key exclusion criteria (1 listed)
- Other Lung Illness
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
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 27 Aug 2026.
- Derived from this study: PubMed 24177001Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.
- Homepage for the Dorothy P. and Richard P. Simmons Center for Interstitial Lung DiseaseLink 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 - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
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, 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 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: looking for participants now, as of the sponsor's last update on 27 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 MacPherson, MAT (412-647-4537, macphersonmj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00373841, which also lists 1 linked publication.
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 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.