Clinical trial NCT04896138: University of Virginia Natural History Study
Official title: A Study of the Natural Progression of Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Sarcoidosis
Connective Tissue Diseases
Hypersensitivity Pneumonitis
Idiopathic Interstitial Pneumonias
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving care in the UVA ILD or Pulmonary clinic

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?

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

Primary outcomes:
measure: Clinical Course of Disease
timeFrame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months
measure: Subject deaths
timeFrame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Imre Noth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia Health System
name: Yousef Althulth, MD
role: STUDY_DIRECTOR
References: