Idiopathic Pulmonary FibrosisGWASNCT01088217
Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
An observational study of Idiopathic Pulmonary Fibrosis and Familial Pulmonary Fibrosis, run by National Jewish Health at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Familial Pulmonary Fibrosis, Idiopathic Interstitial Pneumonia
- How many people
- 8,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2008to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Families with two or more individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)
Who may be able to join
- 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)
Who cannot join
- Individuals whose pulmonary fibrosis is due to a known cause rather than idiopathic
- Individuals whose pulmonary fibrosis is due to a broader genetic syndrome
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Julie Powers, MHS, 303-724-6539, julia.powers@ucdenver.edu
Janet Talbert, MS, CGC, 1-800-423-8891 ext. 1022, talbertj@njhealth.org
- Recruiting
National Jewish Health and University of Colorado Denver
Denver, Colorado, 80206
Janet Talbert, MS, CGC, 800-423-8891 ext. 1022, talbertj@njhealth.org
Julie Powers, MHS, 303-724-6539, julia.powers@ucdenver.edu
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Cheryl Markin, MT, 888-898-1550, cheryl.markin@vanderbilt.edu
James E. Loyd, MD
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University Hospital
Reykjavik
Gunnar Gudmundsson, MD
About this study
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.
- 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
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonias, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startJul 2008
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Vanderbilt University, Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- David A. Schwartz, MD, Principal investigator, University of Colorado Denver; National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088217
- Sponsor's protocol ID
- 2R01HL097163
- Acronym
- GWAS
- Status last verified
- Sep 2020
- First submitted
- 15 Mar 2010
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genetics in Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT01088217
- Acronym / sponsor ID
- GWAS / 2R01HL097163
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Vanderbilt University, Landspitali University Hospital
- Study start
- Jul 2008
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Families with two or more individuals diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Idiopathic Interstitial Pneumonia (IIP)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Individuals whose pulmonary fibrosis is due to a known cause rather than idiopathic
- Individuals whose pulmonary fibrosis is due to a broader genetic syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Click here to learn more about Familial Pulmonary Fibrosis and this study.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Schwartz, MD principal investigator
University of Colorado Denver; National Jewish Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Familial Pulmonary Fibrosis, run by National Jewish Health at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Powers, MHS (303-724-6539, julia.powers@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.