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Enrolling by invitationNCT04896138Updated May 8, 2024

University of Virginia Natural History Study

An observational study in Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis and Sarcoidosis, sponsored by University of Virginia. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Virginia · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 201 studies in Lung Diseases, Interstitial with a site in United States — 67 open to participants now, 83 under way, 19 of them phase 3. Lung Diseases, Interstitial · United States.

Planned enrollment
11th of 60
2,500 · median 327
Started
2018
with 8 others
Observational
61 of 201
17 open now
Primary completion
2035-08
later than 82 of 82 live
Registered
112th of 201
by date

Among the 201 studies in Lung Diseases, Interstitial with a site in United States, this one is the 11th largest by planned enrollment of the 60 observational ones that give a count, is one of 9 that started in 2018, is one of 61 observational ones, reaches primary completion later than 82 of the 82 other live ones, and was the 112th registered.

Lung Diseases, Interstitial

681 studies on the registry are indexed under Lung Diseases, Interstitial; 245 are open to participants now.

Browse Lung Diseases, Interstitial studies →

Open to participants now

67 of the 201 studies in Lung Diseases, Interstitial with a site in United States are open now. Recruiting first, the newest first:

62 more — sign in →

All 67 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 172 Lung Diseases, Interstitial studies recruiting now, 108 (63%) set no upper age limit and 25 (15%) stop at 75 or younger; 13 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 201 studies in Lung Diseases, Interstitial with a site in United States, or all of them as a file.
02

Study summary

Data and specimens will be collected longitudinally from patients seen in the UVA Interstitial Lung Disease (ILD) clinic in order to describe the phenotypic expression of various interstitial lung diseases. Samples will also be collected from a control group for comparison purposes.

All data will be entered into a repository for future research purposes or screening for new studies that become available. This data will help identify trends and hopefully lead to a better understanding of the disease progression, treatment options, and outcomes.

Read the detailed description

Following the clinical course of patients with ILD will allow description of the natural history of these diseases and prospective analysis of the following specific questions:

  1. Can surrogate physiological markers of disease progression be used in place of mortality? Mortality of a defined cohort of patients will be developed. The surrogate markers include but are not limited to serial cardiopulmonary exercise testing, pulmonary function testing, 6-minute walk testing, HRCT scanning and echocardiography.
  2. Do alternative assessments such as quality of life (QOL) questionnaires provide early prediction of physiological change as measured by the previously described parameters? Periodic QOL questionnaires are regularly conducted in clinic and will be followed
  3. Does rate of deterioration as measured by these previously described parameters affect response to therapy? If we pre-identify rapid decliners from stable subjects, does this variable affect the response to whatever therapy is applied?
  4. Can genetic analysis, genomics, proteomics, microbial and other biomarkers in the blood and cheeks provide insight into the polymorphisms and other elements related to the etiology and pathology of the lung damage?
03

Conditions studied

  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
  • Sarcoidosis
  • Connective Tissue Diseases
  • Hypersensitivity Pneumonitis
  • Idiopathic Interstitial Pneumonias
04

Who can participate

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

Study population

Patients receiving care in the UVA ILD or Pulmonary clinic

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

  • Patient presenting to University of Virginia ILD or Pulmonary clinic
  • Family members accompanying patients (as control subjects)

Exclusion criteria

Exclusion Criteria:

  • Control subjects cannot have ILD
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • ILD Cohort

    Patients with Interstitial Lung Disease seen at the UVA ILD or Pulmonary Clinic

    Other: Interstitial Lung Disease

  • Control Cohort

    Control group of patients and family members of those with an Interstitial Lung Disease

Interventions

  • OtherInterstitial Lung Disease

    Not applicable - this is not an interventional trial

06

What researchers measure

Primary outcomes

  1. Clinical Course of Disease

    Course of disease in patients with ILD will be reviewed prospectively for the duration of the study

    Time frame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months

  2. Subject deaths

    Causes of death in patients with ILD will be reviewed prospectively for the duration of the study

    Time frame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — Coded and de-identified data and specimens will be shared with collaborators. MTAs and DUAs are in place for such collaborations. This study also includes a data security plan that includes protective measures for sharing of data between investigators.

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 Aug 2018 (actual). Primary completion is estimated for Aug 2035, 204 months after the start.

Of 111 non-industry observational studies under Lung Diseases, Interstitial, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 274. This study's planned 204 months is above that.

Counting every sponsor, half of 132 studies reached it within 55 months; a quarter within 31 and three quarters within 83.

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

Registered
Apr 26, 2021
First posted
May 21, 2021
StartActual
Aug 28, 2018
Primary completionEst.
Aug 31, 2035
CompletionEst.
Aug 31, 2035
Last update
May 8, 2024
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 May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04896138
Responsible party
Imre Noth, MD (Professor, University of Virginia) — Principal investigator
First posted
May 21, 2021
Start date
Aug 28, 2018
Primary completion
Aug 31, 2035 (estimated)
Completion
Aug 31, 2035 (estimated)
Last update
May 8, 2024

Study contacts

Imre Noth, MD
principal investigator · University of Virginia Health System
Yousef Althulth, MD
study director · University of Virginia Health System

Oversight

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

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