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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Kevin F. Gibson, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00373841
First received: September 6, 2006
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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 to to disease progression.


Condition
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 the disease progression in patient with idiopathic pulmonary fibrosis


Estimated Enrollment: 150
Study Start Date: October 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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.

  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

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

Criteria

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 ClinicalTrials.gov identifier: NCT00373841

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: Luis Ortiz, MD         
Sub-Investigator: Steve Duncan, MD         
Sub-Investigator: Prabhir Ray, PhD         
Sub-Investigator: Yingze Zhang, PhD         
Sub-Investigator: Carol Feghali-Boswick, PhD         
Sub-Investigator: Kathleen R Lindell, MSN, RN         
Sub-Investigator: Lara Chensny         
Sub-Investigator: Melinda J Klesen, B.A.         
Sub-Investigator: Trisha R Black, 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         
Sub-Investigator: Naftali Kaminski, M.D.         
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:
No publications provided by University of Pittsburgh

Additional 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: NCT00373841     History of Changes
Other Study ID Numbers: 0610029
Study First Received: September 6, 2006
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lung
Fibrosis
Idiopathic
Biomarkers
Genomics
Longitudinal

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

ClinicalTrials.gov processed this record on July 23, 2014