University of Virginia Natural History Study

NCT04896138 | Enrolling By Invitation

• 1 other identifier: 20937
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

ILD Cohort

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

Other: Interstitial Lung Disease

Control Cohort

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

Interventions

Interstitial Lung Disease OTHER

Not applicable - this is not an interventional trial

ILD Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving care in the UVA ILD or Pulmonary clinic

You may qualify if:

• Patient presenting to University of Virginia ILD or Pulmonary clinic
• Family members accompanying patients (as control subjects)

You may not qualify if:

• Control subjects cannot have ILD

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Sarcoidosis; Connective Tissue Diseases; Alveolitis, Extrinsic Allergic; Idiopathic Interstitial Pneumonias

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Skin and Connective Tissue Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Imre Noth, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

• Yousef Althulth, MD

  University of Virginia Health System

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 21, 2021
• Study Start: August 28, 2018
• Primary Completion (Estimated): August 31, 2035
• Study Completion (Estimated): August 31, 2035
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1)