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Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF) (GP)

This study is currently recruiting participants.
Verified June 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Kevin F. Gibson, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00258570
First received: November 23, 2005
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.

Condition
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

Blood samples retained for multitude of testing. Consent allows for unrestricted use of samples.


Estimated Enrollment: 1000
Study Start Date: January 2003
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Idiopathic pulmonary fibrosis is one of a collection of severe lung diseases that lead to abnormal inflammation and scarring of the lungs. The accumulation of scar tissue in the lung destroys normal lung tissue and results in the symptoms associated with this disease. The cause of the disease is currently unknown. In this study, we are attempting to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis. We are also attempting to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs. The purpose of this research is to identify genes that control the processes of lung inflammation, lung scarring, and lung repair. As more information becomes available, we will also conduct studies of additional genes that are found to be involved in this disease process.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Under 18 years of age
  • Non-fibrotic ILD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258570

Contacts
Contact: Melinda J Klesen, BA 412-802-6860 ext 26860 klesenmj@upmc.edu
Contact: Trisha R Black, BA 412-605-1550 ext 51550 blacktr@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Sub-Investigator: Yingze Zhang, PhD            
Sub-Investigator: Carol Feghali-Bostwick, PhD            
Sub-Investigator: Sam Yousem, MD            
Sub-Investigator: Rajiv Dhir, MD            
Sub-Investigator: Prabir Ray, PhD            
Sub-Investigator: Steven Duncan, MD            
Sub-Investigator: Kathleen O. Lindell, R.N., M.S.N            
Sub-Investigator: Melinda J Klesen, B.A.            
Sub-Investigator: Trisha R. Black, B.A.            
Sub-Investigator: Luis A Ortiz, M.D.            
Sub-Investigator: Daniel J. Kass, M.D.            
Sub-Investigator: Kristen Veraldi, M.D.            
Principal Investigator: Kevin F. Gibson, M.D.            
Sub-Investigator: Michelle F. MacPherson, BS, MAT            
Sub-Investigator: Michelle Meyers, BSN, RN            
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
Principal Investigator: Naftali Kaminski, M.D. University of Pittsburgh - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease
  More Information

Additional Information:
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.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Kevin F. Gibson, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00258570     History of Changes
Other Study ID Numbers: 020123
Study First Received: November 23, 2005
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
"Lung[A04.400]"

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

ClinicalTrials.gov processed this record on May 23, 2013