Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

— GWAS  

Official title:

Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01088217
• Other study ID #: 2R01HL097163
• Status: Recruiting
• Start date: July 2008
• Est. completion date: June 2025

Study information

• Verified date: September 2020
• Source: National Jewish Health
• Contact: Julie Powers, MHS
• Phone: 303-724-6539
• Email: julia.powers[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Interstitial Pneumonia
• Familial Pulmonary Fibrosis
• Fibrosis
• Idiopathic Interstitial Pneumonia
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis

Locations

Country	Name	City	State
Iceland	Landspitali University Hospital	Reykjavik
United States	University of Colorado Denver	Aurora	Colorado
United States	National Jewish Health and University of Colorado Denver	Denver	Colorado
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
National Jewish Health	Landspitali University Hospital, University of Colorado, Denver, Vanderbilt University

Countries where clinical trial is conducted

United States,  Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 years
Secondary	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.	10 years

External Links

•   Click here to learn more about Familial Pulmonary Fibrosis and this study.