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RecruitingNCT03478553Updated Mar 25, 2025

The Genetics of Pulmonary Fibrosis

An observational study in Idiopathic Pulmonary Fibrosis (IPF), sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States — 37 open to participants now, 52 under way, 8 of them phase 3. Idiopathic Pulmonary Fibrosis · United States.

Planned enrollment
14th of 45
1,000 · median 450
Started
2018
with 14 others
Observational
46 of 236
13 open now
Primary completion
2026-12
later than 11 of 51 live
Registered
120th of 236
by date

Among the 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, this one is the 14th largest by planned enrollment of the 45 observational ones, is one of 15 that started in 2018, is one of 46 observational ones, reaches primary completion later than 11 of the 51 other live ones, and was the 120th registered.

By phase

236 studies; the count open now beside each. This study's row is marked.

Phase 282 · 13 open
Observationalthis study46 · 13 open
Phase 139 · 3 open
Phase 337 · 6 open
No phase18 · 1 open
Phase 46 · 0 open
Phase 1/25 · 1 open
Phase 2/32 · 0 open
Other kind1 · 0 open

By the year they started

First in 1999; this study’s year is marked. 15 started in 2018.

Size and results

Median enrollment 61 across the 188 interventional studies, 450 across the 45 observational. Of the 169 that completed or were terminated, 85 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 236 studies in Idiopathic Pulmonary Fibrosis with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age at least 18 years old
  • Family member diagnosed with IPF

Exclusion criteria

Exclusion Criteria:

  • No family member with IPF
05

Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • People with IPF

    Other: Blood draw · Other: Questionnaire

  • Family members without IPF

    Other: Blood draw · Other: Questionnaire

Interventions

  • OtherBlood draw

    Blood draw

  • OtherQuestionnaire

    Pulmonary Fibrosis Questionnaire

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Dec 2026, 107 months after the start.

Of 74 non-industry observational studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 110. This study's planned 107 months is above that.

Counting every sponsor, half of 88 studies reached it within 54 months; a quarter within 29 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2018
First posted
Mar 27, 2018
StartActual
Jan 18, 2018
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Mar 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03478553
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Jan 18, 2018
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 25, 2025

Study contacts

Rachel Warren
Contact
rachel.warren@cuanschutz.edu
303-724-8569
David A Schwartz, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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