University of Virginia Natural History Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interstitial Lung Disease.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Connective Tissue Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of the Natural Progression of Interstitial Lung Disease
Overview
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
- Other Interstitial Lung Disease
Not applicable - this is not an interventional trial
Primary outcome measures
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Virginia Health System — Charlottesville
Identifiers
NCT: NCT04896138 · 20937