ClinicalTrials.gg
RecruitingNCT01088217GWASUpdated Sep 14, 2020

Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)

An observational study in Idiopathic Pulmonary Fibrosis, Familial Pulmonary Fibrosis and Idiopathic Interstitial Pneumonia, sponsored by National Jewish Health. Recruiting at 4 sites in 2 countries. Per ClinicalTrials.gov, last updated 2020-09-14.

Primary conditionIdiopathic Interstitial PneumoniasRegistry: Idiopathic Pulmonary FibrosisReclassifiedWhy we changed it
Registry
Idiopathic Pulmonary Fibrosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Idiopathic Interstitial Pneumonias
Why
  1. The study's listed conditions name Idiopathic Interstitial Pneumonias, a narrower term within Idiopathic Pulmonary Fibrosis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Jewish Health · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Family-based
Time perspective
Cross-sectional
Enrollment
8,000
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Idiopathic Pulmonary Fibrosis
  • Familial Pulmonary Fibrosis
  • Idiopathic Interstitial Pneumonia
  • Familial Interstitial Pneumonia

Keywords

  • Idiopathic Pulmonary Fibrosis
  • Familial Pulmonary Fibrosis
  • Idiopathic Interstitial Pneumonia
  • Familial Interstitial Pneumonia
  • Pulmonary Fibrosis
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In context

Idiopathic Interstitial Pneumonias Reclassified

27 studies on the registry are indexed under Idiopathic Interstitial Pneumonias; 6 are open to participants now.

This study's planned enrollment of 8,000 is above the median of 300 across 14 observational studies indexed under Idiopathic Interstitial Pneumonias.

Browse Idiopathic Interstitial Pneumonias studies →

Lead sponsor

National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.

Compared within Idiopathic Interstitial Pneumonias, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Idiopathic Pulmonary Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Family-based
Time perspective
Cross-sectional
Enrollment
8,000 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Identify a group of genetic loci that play a role in the development of familial interstitial pneumonia and idiopathic interstitial pneumonia.

    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.

    Time frame: 10 years

Secondary outcomes

  1. 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).

    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.

    Time frame: 10 years

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Study locations

4 of 4 sites recruiting
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
    Recruiting
    • Julie Powers, MHS · Contactjulia.powers@ucdenver.edu · 303-724-6539
    • Janet Talbert, MS, CGC · Contacttalbertj@njhealth.org · 1-800-423-8891
    • David A. Schwartz, MD · Principal 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 · Sub investigator
  • National Jewish Health and University of Colorado Denver
    Denver, Colorado 80206, United States
    Recruiting
    • Janet Talbert, MS, CGC · Contacttalbertj@njhealth.org · 800-423-8891
    • Julie Powers, MHS · Contactjulia.powers@ucdenver.edu · 303-724-6539
    • David A. Schwartz, MD · Principal 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 · Sub investigator
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
    Recruiting
  • Landspitali University Hospital
    Reykjavik, Iceland
    Recruiting
    • Gunnar Gudmundsson, MD · Principal investigator
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01088217
Collaborators
University of Colorado, Denver, Vanderbilt University, Landspitali University Hospital
Responsible party
Sponsor
First posted
Mar 17, 2010
Start date
Jul 2008
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Sep 14, 2020

Study contacts

Julie Powers, MHS
Contact
julia.powers@ucdenver.edu
303-724-6539
Janet Talbert, MS, CGC
Contact
talbertj@njhealth.org
1-800-423-8891 ext. 1022
David A. Schwartz, MD
principal investigator · University of Colorado Denver; National Jewish Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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