Interstitial Lung DiseaseNCT04896138
University of Virginia Natural History Study
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis
- What is being tested?
- Interstitial Lung Disease
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 31 Aug 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving care in the UVA ILD or Pulmonary clinic
Who may be able to join
- Patient presenting to University of Virginia ILD or Pulmonary clinic
- Family members accompanying patients (as control subjects)
Who cannot join
- Control subjects cannot have ILD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: A Study of the Natural Progression of Interstitial Lung Disease
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:
- 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?
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Connective Tissue Diseases, Hypersensitivity Pneumonitis, Idiopathic Interstitial Pneumonias
- Being tested
- Interstitial Lung Disease
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Connective Tissue Diseases, Alveolitis, Extrinsic Allergic, Idiopathic Interstitial Pneumonias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial Lung DiseaseOther
Not applicable - this is not an interventional trial
| Study group | Role | What they receive |
|---|---|---|
| ILD Cohort | Patients with Interstitial Lung Disease seen at the UVA ILD or Pulmonary Clinic Receives: Other: Interstitial Lung Disease | |
| Control Cohort | Control group of patients and family members of those with an Interstitial Lung Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Course of Disease
Course of disease in patients with ILD will be reviewed prospectively for the duration of the study
Measured: 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
Measured: Yearly from date of consent until subject is lost to follow-up or death occurs, whichever comes first, assessed up to 144 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start28 Aug 2018
- Primary completion31 Aug 2035 (estimated)
- Study completion31 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imre Noth, MD, University of Virginia
- Investigators
- Imre Noth, MD, Principal investigator, University of Virginia Health SystemYousef Althulth, MD, Study director, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896138
- Sponsor's protocol ID
- 20937
- Status last verified
- May 2024
- First submitted
- 26 Apr 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Natural Progression of Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04896138
- Acronym / sponsor ID
- 20937
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Connective Tissue Diseases, Hypersensitivity Pneumonitis, Idiopathic Interstitial Pneumonias
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 31 Aug 2035 (estimated)
- Study completion
- 31 Aug 2035 (estimated)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILD Cohort | – | Other: Interstitial Lung DiseasePatients with Interstitial Lung Disease seen at the UVA ILD or Pulmonary Clinic |
| Control Cohort | – | –Control group of patients and family members of those with an Interstitial Lung Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving care in the UVA ILD or Pulmonary clinic
Key inclusion criteria (2 listed)
- Patient presenting to University of Virginia ILD or Pulmonary clinic
- Family members accompanying patients (as control subjects)
Key exclusion criteria (1 listed)
- Control subjects cannot have ILD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interstitial Lung DiseaseNot applicable - this is not an interventional trial | Other | ILD Cohort |
Primary outcome
Clinical Course of Disease
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
Course of disease in patients with ILD will be reviewed prospectively for the duration of the study
Subject deaths
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
Causes of death in patients with ILD will be reviewed prospectively for the duration of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: 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.
Related trials for Interstitial Lung Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imre Noth, MD principal investigator
University of Virginia Health System
Yousef Althulth, MD study director
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Course of Disease (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.