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Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF) (GWAS)

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ClinicalTrials.gov Identifier: NCT01088217
Recruitment Status : Recruiting
First Posted : March 17, 2010
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Vanderbilt University
Landspitali University Hospital
Information provided by (Responsible Party):
National Jewish Health

Tracking Information
First Submitted Date March 15, 2010
First Posted Date March 17, 2010
Last Update Posted Date September 14, 2020
Study Start Date July 2008
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2013)		 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 ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2013)		 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 ]
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Official Title Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, plasma, lung tissue, DNA, RNA
Sampling Method Non-Probability Sample
Study Population Families with two or more individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)
Condition
  • Idiopathic Pulmonary Fibrosis
  • Familial Pulmonary Fibrosis
  • Idiopathic Interstitial Pneumonia
  • Familial Interstitial Pneumonia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 16, 2010)		 8000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
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
Listed Location Countries Iceland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01088217
Other Study ID Numbers 2R01HL097163( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party National Jewish Health
Original Responsible Party David A. Schwartz, M.D., National Jewish Health
Current Study Sponsor National Jewish Health
Original Study Sponsor Same as current
Collaborators
  • University of Colorado, Denver
  • Vanderbilt University
  • Landspitali University Hospital
Investigators
Principal Investigator: David A. Schwartz, MD University of Colorado Denver; National Jewish Health
PRS Account National Jewish Health
Verification Date September 2020