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University of Virginia Natural History Study

A Study of the Natural Progression of Interstitial Lung Disease

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04896138
Enrollment
2500
Registered
2021-05-21
Start date
2018-08-28
Completion date
2035-08-31
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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?

Interventions

OTHERInterstitial Lung Disease

Not applicable - this is not an interventional trial

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Control subjects cannot have ILD

Design outcomes

Primary

MeasureTime frameDescription
Clinical Course of DiseaseYearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 monthsCourse of disease in patients with ILD will be reviewed prospectively for the duration of the study
Subject deathsYearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 monthsCauses of death in patients with ILD will be reviewed prospectively for the duration of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026