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OpenTrials
Enrolling by Invitation

NCT Number: NCT04896138

University of Virginia Natural History Study

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.

Enrolling by Invitation

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Key information

About this study

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:

  • 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.
  • 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
  • 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?
  • 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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interstitial Lung Disease

Other

Not applicable - this is not an interventional trial

Primary outcomes

  1. Clinical Course of Disease

    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

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

  2. Subject deaths

    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

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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

A Study of the Natural Progression of Interstitial Lung Disease

Important dates

Study start
2018
Primary completion
2035
Study completion
2035
First posted
May 21, 2021
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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