Pulmonary FibrosisMAANCT00258544
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
An observational study of Pulmonary Fibrosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to 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: Population includes any patients seen at the Simmons Center for Interstitial Lung Disease with the possibility of having the diagnosis of Idiopathic Pulmonary Fibrosis who's physician has ordered an open Lung Biopsy. To check for the disease also known as IPF.
Who may be able to join
- 18 years or age or older
- Diagnosis of pulmonary fibrosis
- Undergoing open lung biopsy
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis
This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.
Read the detailed description
Subjects are being asked to participate in a research study that is investigating the way the lung is damaged in a condition called pulmonary fibrosis. These research studies are conducted in the laboratory on a portion of the tissue from the subject's lung biopsy that was performed by a surgeon. The lung biopsy is to be performed for clinical purposes to diagnose the cause of the subject's lung disease. The tissue used for the research study will in no way interfere with the ability of the pathologist to establish a diagnosis. In addition, the results of your breathing tests, chest X-rays and CT scans, and diagnosis made from the lung biopsy (and slides) will be collected. The goal of the study is to gain an understanding of the causes of pulmonary fibrosis and why it gets worse, which may ultimately lead to new therapies for this disease. Once the lung biopsies are obtained, the pathologist will examine the tissue and determine if there is a sufficient amount available to use in the study without compromising their ability to make a diagnosis. If so, the lung biopsy will be divided. One portion will be submitted to the research study and the other processed by the pathologist in the usual manner to make a diagnosis. The decision to use tissue for the research study will be at the complete discretion of the pathologists. The tissue used in the study will be further processed in the laboratory in order to analyze for the presence of genetic markers in the scarred tissue that are not present in normal. The identification of these unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.
- Conditions
- Pulmonary Fibrosis
- Keywords
- Lung, Fibrosis, Idiopathic, Microarray, Tissue, Biopsy
- Medical subject headings
- Pulmonary Fibrosis, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
Microarray gene expression analysis involves the extraction of RNA from cells, synthesizing cDNA to hydridize to a probe array of genes, scanning signal intensities, and normalizing data to analyze probe-level expression for differential genes, Other methods of analyzing differential gene expression including Bulk RN-seq, and single cell RNA-seq will allow be employed where feasible.
Measured: The time frame is open-ended with the goal of creating a bank of samples to support an indeterminant number of well phenotypes samples for studies of IPF.
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 startOct 2001
- 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 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
- 80 participants (actual)
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
- NCT00258544
- Sponsor's protocol ID
- STUDY20070385
- Acronym
- MAA
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2005
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pandit KV, Corcoran D, Yousef H, Yarlagadda M, Tzouvelekis A, Gibson KF, Konishi K, Yousem SA, Singh M, Handley D, Richards T, Selman M, Watkins SC, Pardo A, Ben-Yehudah A, Bouros D, Eickelberg O, Ray P, Benos PV, Kaminski N. Inhibition and role of let-7d in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2010 Jul 15;182(2):220-9. doi: 10.1164/rccm.200911-1698OC. Epub 2010 Apr 15.
PubMed 20395557
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
- Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00258544
- Acronym / sponsor ID
- MAA / STUDY20070385
- Conditions
- Pulmonary Fibrosis
- Keywords
- Lung, Fibrosis, Idiopathic, Microarray, Tissue, Biopsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (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.
This study is investigating the way the lung is damaged in a condition called pulmonary fibrosis. Research studies will be conducted on lung tissue obtained from an open lung biopsy performed by the subject's surgeon. The identification of unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.
Detailed description
Subjects are being asked to participate in a research study that is investigating the way the lung is damaged in a condition called pulmonary fibrosis. These research studies are conducted in the laboratory on a portion of the tissue from the subject's lung biopsy that was performed by a surgeon. The lung biopsy is to be performed for clinical purposes to diagnose the cause of the subject's lung disease. The tissue used for the research study will in no way interfere with the ability of the pathologist to establish a diagnosis. In addition, the results of your breathing tests, chest X-rays and CT scans, and diagnosis made from the lung biopsy (and slides) will be collected. The goal of the study is to gain an understanding of the causes of pulmonary fibrosis and why it gets worse, which may ultimately lead to new therapies for this disease. Once the lung biopsies are obtained, the pathologist will examine the tissue and determine if there is a sufficient amount available to use in the study without compromising their ability to make a diagnosis. If so, the lung biopsy will be divided. One portion will be submitted to the research study and the other processed by the pathologist in the usual manner to make a diagnosis. The decision to use tissue for the research study will be at the complete discretion of the pathologists. The tissue used in the study will be further processed in the laboratory in order to analyze for the presence of genetic markers in the scarred tissue that are not present in normal. The identification of these unique genetic markers of scarred lung may ultimately lead to new approaches to the diagnosis and treatment of pulmonary fibrosis.
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
- Population includes any patients seen at the Simmons Center for Interstitial Lung Disease with the possibility of having the diagnosis of Idiopathic Pulmonary Fibrosis who's physician has ordered an open Lung Biopsy. To check for the disease also known as IPF.
Key inclusion criteria (3 listed)
- 18 years or age or older
- Diagnosis of pulmonary fibrosis
- Undergoing open lung biopsy
Key exclusion criteria (1 listed)
- N/A
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
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
Time frame: The time frame is open-ended with the goal of creating a bank of samples to support an indeterminant number of well phenotypes samples for studies of IPF.
Microarray gene expression analysis involves the extraction of RNA from cells, synthesizing cDNA to hydridize to a probe array of genes, scanning signal intensities, and normalizing data to analyze probe-level expression for differential genes, Other methods of analyzing differential gene expression including Bulk RN-seq, and single cell RNA-seq will allow be employed where feasible.
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.
- Derived from this study: PubMed 20395557Pandit KV, Corcoran D, Yousef H, Yarlagadda M, Tzouvelekis A, Gibson KF, Konishi K, Yousem SA, Singh M, Handley D, Richards T, Selman M, Watkins SC, Pardo A, Ben-Yehudah A, Bouros D, Eickelberg O, Ray P, Benos PV, Kaminski N. Inhibition and role of let-7d in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2010 Jul 15;182(2):220-9. doi: 10.1164/rccm.200911-1698OC. Epub 2010 Apr 15.
- The Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease website.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. This study is not recruiting at the moment.
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 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: under way, not looking for participants, 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?
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?
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF) (time frame: The time frame is open-ended with the goal of creating a bank of samples to support an indeterminant number of well phenotypes samples for studies of IPF.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00258544, 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 31 Aug 2026.