University of Virginia Natural History Study

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Study of the Natural Progression of Interstitial Lung Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04896138
• Other study ID #: 20937
• Status: Enrolling by invitation
• Start date: August 28, 2018
• Est. completion date: August 31, 2035

Study information

• Verified date: May 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: August 31, 2035
• Est. primary completion date: August 31, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Connective Tissue Diseases
• Hypersensitivity
• Hypersensitivity Pneumonitis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis
• Sarcoidosis

Intervention

Other:
• Interstitial Lung Disease
Not applicable - this is not an interventional trial

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Course of Disease	Course of disease in patients with ILD will be reviewed prospectively for the duration of the study	Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months
Primary	Subject deaths	Causes of death in patients with ILD will be reviewed prospectively for the duration of the study	Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months