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Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF) (MAA)

This study is currently recruiting participants.
Verified July 2017 by Kevin F. Gibson, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258544
First Posted: November 24, 2005
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kevin F. Gibson, University of Pittsburgh
  Purpose
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.

Condition
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Kevin F. Gibson, University of Pittsburgh:

Biospecimen Retention:   Samples With DNA
Lung Tissue from a Lung Biopsy ordered by the patients physician. Also, a blood sample may be collected at the researchers discretion as listed in the addendum consent form.

Estimated Enrollment: 150
Study Start Date: October 2001
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 18 years or age or older
  • Diagnosis of pulmonary fibrosis
  • Undergoing open lung biopsy

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258544


Contacts
Contact: Melinda J Klesen, BA 412-802-6860 klesenmj@upmc.edu
Contact: Morgan L Kirkpatrick, BS 412-692-2151 ext 22151 kirkpatrickml@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melinda J Klesen, BA    412-802-6860 ext 26860    klesenmj@upmc.edu   
Contact: Morgan L Kirkpatrick, BS    412-692-2151 ext 22151    kirkpatrickml@upmc.edu   
Sub-Investigator: Rajiv Dhir, MD         
Sub-Investigator: Sam Yousem, MD         
Sub-Investigator: James Luketich, MD         
Sub-Investigator: Luis A Ortiz, MD         
Sub-Investigator: Melinda J Klesen, BA         
Sub-Investigator: Kathleen O Lindell, RN, MSN, PhD         
Sub-Investigator: Michelle MacPherson, BS, MAT         
Sub-Investigator: Michelle Meyers, BSN, RN         
Principal Investigator: Kevin F Gibson, MD         
Sub-Investigator: Sally Wenzel, MD         
Sub-Investigator: Danny Kass, MD         
Sub-Investigator: Kristen Veraldi, MD         
Sub-Investigator: Fernando Holguin, MD         
Sub-Investigator: Chester Oddis, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Frank Schneider, MD         
Sub-Investigator: Morgan Kirkpatrick, BS         
Sub-Investigator: Humberto Trejo Bittar, MD         
Sub-Investigator: Daniel Doberer, MD         
Sub-Investigator: Catherine Vitari, RN, BSN         
Sub-Investigator: Jonathan D'Cunha, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kevin F Gibson, MD University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin F. Gibson, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00258544     History of Changes
Other Study ID Numbers: 010462
First Submitted: November 23, 2005
First Posted: November 24, 2005
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Kevin F. Gibson, University of Pittsburgh:
Lung
Fibrosis
Idiopathic
Microarray
Tissue
Biopsy

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial