University of Virginia Natural History Study

Sponsor

University of Virginia (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04896138

Collaborator

(none)

2,500

Enrollment

Location

204.1

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Sarcoidosis Connective Tissue Diseases Hypersensitivity Pneumonitis Idiopathic Interstitial Pneumonias	Other: Interstitial Lung Disease

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:

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?

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

A Study of the Natural Progression of Interstitial Lung Disease

Actual Study Start Date :

Aug 28, 2018

Anticipated Primary Completion Date :

Aug 31, 2035

Anticipated Study Completion Date :

Aug 31, 2035

Arms and Interventions

Arm	Intervention/Treatment
ILD Cohort Patients with Interstitial Lung Disease seen at the UVA ILD or Pulmonary Clinic	Other: Interstitial Lung Disease Not applicable - this is not an interventional trial
Control Cohort Control group of patients and family members of those with an Interstitial Lung Disease

Arm

Intervention/Treatment

ILD Cohort

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

Other: Interstitial Lung Disease

Not applicable - this is not an interventional trial

Control Cohort

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

Outcome Measures

Primary Outcome Measures

Clinical Course of Disease [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
Subject deaths [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