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Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis (IPF) (GAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Pittsburgh
Information provided by (Responsible Party):
Kevin F. Gibson, University of Pittsburgh Identifier:
First received: September 6, 2006
Last updated: January 4, 2016
Last verified: January 2016
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.

Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Genomic and Proteomic Analysis of Disease Progression in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA
Blood samples necessary to analyze disease progression in patient with idiopathic pulmonary fibrosis over a long period of time.

Estimated Enrollment: 500
Study Start Date: October 2005
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
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.

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
Patients aged 18 and older who have been diagnosed with IPF and referred by a Simmons Center doctor.

Inclusion Criteria:

  • Patients who are 18 or older
  • Diagnosis of Idiopathic Pulmonary Fibrosis
  • Treated at the Simmons Center

Exclusion Criteria:

  • Other Lung Illness
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00373841

Contact: Melinda J Klesen, BA 412-802-6860 ext 26860
Contact: Morgan L Kirkpatrick, BS 412-692-2151 ext 22151

United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melinda J Klesen, BA    412-802-6860 ext 26860   
Contact: Morgan L Kirkpatrick, BS    412-692-2151 ext 22151   
Sub-Investigator: Luis Ortiz, MD         
Sub-Investigator: Prabhir Ray, PhD         
Sub-Investigator: Yingze Zhang, PhD         
Sub-Investigator: Kathleen R Lindell, MSN, RN PhD         
Sub-Investigator: Melinda J Klesen, B.A.         
Sub-Investigator: Kristen Veraldi, M.D.         
Sub-Investigator: Daniel J. Kass, M.D.         
Sub-Investigator: Michelle F. MacPherson, BS, MAT         
Sub-Investigator: Michelle Meyers, BSN, RN         
Principal Investigator: Kevin F Gibson, MD         
Sub-Investigator: Morgan L Kirkpatrick, BS         
Sub-Investigator: Frank Schneider, MD         
Sub-Investigator: Samuel Yousem, MD         
Sub-Investigator: Mauricio Rojas, MD         
Sub-Investigator: Melissa Saul         
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Kevin F Gibson, M.D 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 Identifier (NCT Number):
Responsible Party: Kevin F. Gibson, Professor of Medicine, University of Pittsburgh Identifier: NCT00373841     History of Changes
Other Study ID Numbers: 0610029
Study First Received: September 6, 2006
Last Updated: January 4, 2016

Keywords provided by University of Pittsburgh:

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Disease Progression
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Disease Attributes processed this record on April 26, 2017