University of Virginia Natural History Study

NCT ID: NCT04896138

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2035-08-31

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?

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Sarcoidosis; Connective Tissue Diseases; Hypersensitivity Pneumonitis; Idiopathic Interstitial Pneumonias

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

ILD Cohort

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

Interstitial Lung Disease

Intervention Type: OTHER

Not applicable - this is not an interventional trial

Control Cohort

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

No interventions assigned to this group

Interventions

Interstitial Lung Disease

Not applicable - this is not an interventional trial

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Imre Noth, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imre Noth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Yousef Althulth, MD

Role: STUDY_DIRECTOR

University of Virginia Health System

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

20937

Identifier Type: -

Identifier Source: org_study_id