- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258544
Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF) (MAA)
August 26, 2026 updated by: Kevin F. Gibson, University of Pittsburgh
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 18 years or age or older
- Diagnosis of pulmonary fibrosis
- Undergoing open lung biopsy
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin F Gibson, MD, University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Study Registration Dates
First Submitted
November 23, 2005
First Submitted That Met QC Criteria
November 23, 2005
First Posted (Estimated)
November 24, 2005
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20070385
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.