A Linkage and Association Study in Pulmonary Fibrosis (GWAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Jewish Health
Sponsor:
Collaborators:
University of Colorado, Denver
Vanderbilt University
Landspitali University Hospital
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01088217
First received: March 15, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to investigate inherited genetic factors that play a role in the development of familial pulmonary fibrosis and to identify a group of genes that predispose individuals to develop pulmonary fibrosis. Finding the genes that cause pulmonary fibrosis is the first step at developing better methods for early diagnosis and improved treatment for pulmonary fibrosis. The overall hypothesis is that inherited genetic factors predispose individuals to develop pulmonary fibrosis.


Condition
Idiopathic Pulmonary Fibrosis
Familial Pulmonary Fibrosis
Idiopathic Interstitial Pneumonia
Familial Interstitial Pneumonia

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: GWAS in Fibrosing Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Identify a group of genetic loci that play a role in the development of familial interstitial pneumonia and idiopathic interstitial pneumonia. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    The purpose of this study is to investigate inherited genetic factors that play a role in the development of pulmonary fibrosis and to identify a group of genetic loci/genes that predispose individuals to develop IIP. We will achieve this goal by employing various methods of genetic technology for gene discovery.


Secondary Outcome Measures:
  • Develop biomarkers using proteomic and genomic approaches that will facilitate establishing the diagnosis and prognosis of both familial and sporadic forms of idiopathic interstitial pneumonia (IIP). [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    A peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease. A peripheral blood biomarker for the diagnosis of IIPs and other interstitial lung diseases (ILDs) will potentially decrease the need for invasive surgical lung biopsy, and thereby avoid the additional cost, morbidity, and mortality associated with surgical lung biopsy.


Biospecimen Retention:   Samples With DNA

whole blood, serum, plasma, lung tissue, DNA, RNA


Estimated Enrollment: 8000
Study Start Date: July 2008
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Familial Pulmonary Fibrosis (FPF) is a sub-category of the idiopathic interstitial pneumonias (IIPs). IIPs are progressive lung conditions, with limited treatment options and unknown etiology. Though the IIPs have been associated with both genetic risk factors and environmental exposures, the molecular mechanism underlying disease progression remain poorly understood. This investigation seeks to identify a group of genetic loci that play a role in the development of familial interstitial pneumonia (FIP) or FPF, where 2 or more cases of IIP are seen within a family.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Families with two or more individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)

Criteria

Inclusion Criteria:

  • Two or more family members with a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)
  • Additional family members may be eligible to participate if two family members are suspected of or diagnosed as having Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)

Exclusion Criteria:

  • Individuals whose pulmonary fibrosis is due to a known cause rather than idiopathic
  • Individuals whose pulmonary fibrosis is due to a broader genetic syndrome
  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: NCT01088217

Contacts
Contact: Julie Powers, MHS 303-724-6539 julia.powers@ucdenver.edu
Contact: Janet Talbert, MS, CGC 1-800-423-8891 ext 1022 talbertj@njhealth.org

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Julie Powers, MHS    303-724-6539    julia.powers@ucdenver.edu   
Contact: Janet Talbert, MS, CGC    1-800-423-8891 ext 1022    talbertj@njhealth.org   
Principal Investigator: David A. Schwartz, MD         
Sub-Investigator: Marvin I Schwarz, MD         
Sub-Investigator: Ivana Yang, PhD         
Sub-Investigator: Tasha E Fingerlin, PhD         
Sub-Investigator: Rebecca Keith, MD         
Sub-Investigator: Carlyne Cool, MD         
Sub-Investigator: Anna Peljto, DrPh         
National Jewish Health and University of Colorado Denver Recruiting
Denver, Colorado, United States, 80206
Contact: Janet Talbert, MS, CGC    800-423-8891 ext 1022    talbertj@njhealth.org   
Contact: Julie Powers, MHS    303-724-6539    julia.powers@ucdenver.edu   
Principal Investigator: David A. Schwartz, MD         
Sub-Investigator: Kevin K. Brown, MD         
Sub-Investigator: Gregory P. Cosgrove, MD         
Sub-Investigator: Marvin I. Schwarz, MD         
Sub-Investigator: Tasha Fingerlin, PhD         
Sub-Investigator: Steve Groshong, MD, PhD         
Sub-Investigator: David Lynch, MD         
Sub-Investigator: James Crapo, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cheryl Markin, MT    888-898-1550    cheryl.markin@vanderbilt.edu   
Principal Investigator: James E. Loyd, MD         
Iceland
Landspitali University Hospital Recruiting
Reykjavik, Iceland
Principal Investigator: Gunnar Gudmundsson, MD         
Sponsors and Collaborators
National Jewish Health
University of Colorado, Denver
Vanderbilt University
Landspitali University Hospital
Investigators
Principal Investigator: David A. Schwartz, MD University of Colorado Denver; National Jewish Health
  More Information

Additional Information:
No publications provided

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01088217     History of Changes
Other Study ID Numbers: 1RO1HL097163
Study First Received: March 15, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Idiopathic Pulmonary Fibrosis
Familial Pulmonary Fibrosis
Idiopathic Interstitial Pneumonia
Familial Interstitial Pneumonia
Pulmonary Fibrosis

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

ClinicalTrials.gov processed this record on July 24, 2014