NCT01088217

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

16.9 years

First QC Date

March 15, 2010

Last Update Submit

September 11, 2020

Conditions

Keywords

Idiopathic Pulmonary FibrosisFamilial Pulmonary FibrosisIdiopathic Interstitial PneumoniaFamilial Interstitial PneumoniaPulmonary Fibrosis

Outcome Measures

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.

    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).

    10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

National Jewish Health and University of Colorado Denver

Denver, Colorado, 80206, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

Landspitali University Hospital

Reykjavik, Iceland

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisIdiopathic Interstitial PneumoniasPulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David A. Schwartz, MD

    University of Colorado Denver; National Jewish Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Talbert, MS, CGC

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 17, 2010

Study Start

July 1, 2008

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations