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Enrolling by invitationNCT04896138Updated May 8, 2024

University of Virginia Natural History Study

An observational study in Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis and Sarcoidosis, sponsored by University of Virginia. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Virginia · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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?
02

Conditions studied

  • Interstitial Lung Disease
  • Idiopathic Pulmonary Fibrosis
  • Sarcoidosis
  • Connective Tissue Diseases
  • Hypersensitivity Pneumonitis
  • Idiopathic Interstitial Pneumonias
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients receiving care in the UVA ILD or Pulmonary clinic

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Control subjects cannot have ILD
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherInterstitial Lung Disease

    Not applicable - this is not an interventional trial

05

What researchers measure

Primary outcomes

  1. Clinical Course of Disease

    Course of disease in patients with ILD will be reviewed prospectively for the duration of the study

    Time frame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months

  2. Subject deaths

    Causes of death in patients with ILD will be reviewed prospectively for the duration of the study

    Time frame: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months

06

Study locations

1 site
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
07

References and documents

Individual participant data

Plan to share: Undecided — Coded and de-identified data and specimens will be shared with collaborators. MTAs and DUAs are in place for such collaborations. This study also includes a data security plan that includes protective measures for sharing of data between investigators.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04896138
Lead sponsor
University of Virginia
Responsible party
Imre Noth, MD (Professor, University of Virginia) — Principal investigator
First posted
May 21, 2021
Start date
Aug 28, 2018
Primary completion
Aug 31, 2035 (estimated)
Completion
Aug 31, 2035 (estimated)
Last update
May 8, 2024

Study contacts

Imre Noth, MD
principal investigator · University of Virginia Health System
Yousef Althulth, MD
study director · University of Virginia Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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