Clinical trial NCT01088217: Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Official title: Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Vanderbilt University
name: Landspitali University Hospital
First posted: 2010-03-17
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families with two or more individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)

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.

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

Primary outcomes:
measure: Identify a group of genetic loci that play a role in the development of familial interstitial pneumonia and idiopathic interstitial pneumonia.
timeFrame: 10 years
Secondary outcomes:
measure: 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).
timeFrame: 10 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: National Jewish Health and University of Colorado Denver
state: Colorado
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
Study officials:
affiliation: University of Colorado Denver; National Jewish Health
name: David A. Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: