Idiopathic Pulmonary Fibrosis (IPF)NCT03478553
The Genetics of Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Blood draw and Questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include up to 20,000 people in the country, both people with IPF and their family members who have never been diagnosed with IPF.
Who may be able to join
- Age at least 18 years old
- Family member diagnosed with IPF
Who cannot join
- No family member with IPF
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Rachel Warren, BA, 303-724-8569, rachel.bochantin@ucdenver.edu
Maria Rodriguez, BA, 303-724-0738
About this study
Official title: Idiopathic Pulmonary Fibrosis, a Disease Initiated by Mucociliary Dysfunction
This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.
Read the detailed description
The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Blood draw, Questionnaire
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawOther
Blood draw
QuestionnaireOther
Pulmonary Fibrosis Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| People with IPF | Not described Receives: Other: Blood draw; Other: Questionnaire | |
| Family members without IPF | Not described Receives: Other: Blood draw; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives.
The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start18 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David A Schwartz, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478553
- Sponsor's protocol ID
- 15-1147
- Other IDs
- W81XWH-17-1-0597_1a
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2018
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis, a Disease Initiated by Mucociliary Dysfunction
- ClinicalTrials.gov ID
- NCT03478553
- Acronym / sponsor ID
- 15-1147
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2018 (actual)
- 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.
This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.
Detailed description
The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with IPF | – | Other: Blood draw, Other: Questionnaire |
| Family members without IPF | – | Other: Blood draw, Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include up to 20,000 people in the country, both people with IPF and their family members who have never been diagnosed with IPF.
Key inclusion criteria (2 listed)
- Age at least 18 years old
- Family member diagnosed with IPF
Key exclusion criteria (1 listed)
- No family member with IPF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw | Other | Family members without IPF, People with IPF |
| QuestionnairePulmonary Fibrosis Questionnaire | Other | Family members without IPF, People with IPF |
Primary outcome
Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives.
Time frame: Baseline
The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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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.
David A Schwartz, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by University of Colorado, Denver at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Warren (303-724-8569, rachel.warren@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives. (time frame: Baseline). 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 25 Mar 2025.