SclerodermaNCT04535245
Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD
An observational study of Scleroderma, run by National Jewish Health at 1 site in United States.
Trial summary
This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- LCI testing
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 15 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Scleroderma patients without lung disease
Who may be able to join
- Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
- age 21-75
- No evidence of Scleroderma related Lung disease (ILD)
- Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.
Who cannot join
- Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
- Patients with evidence of lung involvement based upon; Thoracic imaging, abnormal Pulmonary Function Tests (PFTs); Forced Vital Capacity( FVC), Forced Expiratory Volume in 1 second (FEV1) or a Diffusion Capacity for Carbon Monoxide (DLCO) < the Lower Limit of Normal (LLN) or Saturation of Oxygen in arterial blood (SaO2) < 90% .
- Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
- < 21 or > 75 years of age
- Must not be pregnant or had eye surgery within 2 weeks of LCI testing
- Must be able to comprehend and sign an IRB approved consent form and complete LCI testing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Richard T Meehan, MD, 303-398-1475, meehanr@njhealth.org
Mehrnaz Maleki, MD
About this study
Official title: Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD
This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.
Read the detailed description
50 scleroderma patients without evidence of lung disease who have been seen by an NJH Rheumatologist will be invited to participate. They will have their medical records reviewed to determine eligibility and then perform hand held spirometry and LCI testing. This measures evidence of small airway airflow obstruction and requires normal breathing while first on room air followed by inhaling a gas mixture of 100% oxygen. The Oxygen concentration in exhaled breathing and the number of breaths needed to return to room air concentration of Oxygen will be analyzed by a computer. Medical information from the EMR will be recorded and placed in a secure database, REDCap, for statistical analysis to determine if LCI results or other clinical features are predictive of which Scleroderma patients are most likely to subsequently develop evidence of Interstitial Lung disease (ILD) based upon yearly phone call interviews and EMR record reviews within 5 years of baseline testing.
- Conditions
- Scleroderma
- Being tested
- LCI testing
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCI testingDiagnostic test
Also called no drugs will be administered
all subjects will have LCI testing then contacted via a phone interview or EMR review yearly times 5 to determine if they have subsequently developed ILD
| Study group | Role | What they receive |
|---|---|---|
| LCI testing | LCI testing will be performed on all study subjects Receives: Diagnostic Test: LCI testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Utility of Lung Clearance Index Scores at predicting Interstitial Lung disease ( ILD) development within 5 years among Scleroderma patients without ILD.
Lung clearance index values (LCI) will be measured from all Scleroderma patients at baseline (normal value is < 7 ). The LCI scores from the cohort of Scleroderma patients who subsequently develop ILD based upon physician review of the EMR or phone interviews will be compared to the LCI scores from those scleroderma patients who did not develop ILD. Statistical analysis of LCI scores between both cohorts will determine the potential clinical utility of this non-invasive measurement of lung function in identifying those scleroderma patients who are at greatest risk for the subsequent development of ILD so treatment can be initiated early in their disease before irreversible pulmonary fibrosis develops.
Measured: 5 years after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start4 Jan 2021
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Meehan, National Jewish Health
- Investigators
- Richard T Meehan, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535245
- Sponsor's protocol ID
- HS 3471
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD
- ClinicalTrials.gov ID
- NCT04535245
- Acronym / sponsor ID
- HS 3471
- Conditions
- Scleroderma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 1 Sep 2020 (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.
This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.
Detailed description
50 scleroderma patients without evidence of lung disease who have been seen by an NJH Rheumatologist will be invited to participate. They will have their medical records reviewed to determine eligibility and then perform hand held spirometry and LCI testing. This measures evidence of small airway airflow obstruction and requires normal breathing while first on room air followed by inhaling a gas mixture of 100% oxygen. The Oxygen concentration in exhaled breathing and the number of breaths needed to return to room air concentration of Oxygen will be analyzed by a computer. Medical information from the EMR will be recorded and placed in a secure database, REDCap, for statistical analysis to determine if LCI results or other clinical features are predictive of which Scleroderma patients are most likely to subsequently develop evidence of Interstitial Lung disease (ILD) based upon yearly phone call interviews and EMR record reviews within 5 years of baseline testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LCI testing | – | Diagnostic Test: LCI testingLCI testing will be performed on all study subjects |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Scleroderma patients without lung disease
Key inclusion criteria (4 listed)
- Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
- age 21-75
- No evidence of Scleroderma related Lung disease (ILD)
- Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.
Key exclusion criteria (6 listed)
- Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
- Patients with evidence of lung involvement based upon; Thoracic imaging, abnormal Pulmonary Function Tests (PFTs); Forced Vital Capacity( FVC), Forced Expiratory Volume in 1 second (FEV1) or a Diffusion Capacity for Carbon Monoxide (DLCO) < the Lower Limit of Normal (LLN) or Saturation of Oxygen in arterial blood (SaO2) < 90% .
- Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
- < 21 or > 75 years of age
- Must not be pregnant or had eye surgery within 2 weeks of LCI testing
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 |
|---|---|---|
| LCI testingAlso: no drugs will be administeredall subjects will have LCI testing then contacted via a phone interview or EMR review yearly times 5 to determine if they have subsequently developed ILD | Diagnostic test | LCI testing |
Primary outcome
The Utility of Lung Clearance Index Scores at predicting Interstitial Lung disease ( ILD) development within 5 years among Scleroderma patients without ILD.
Time frame: 5 years after baseline testing
Lung clearance index values (LCI) will be measured from all Scleroderma patients at baseline (normal value is < 7 ). The LCI scores from the cohort of Scleroderma patients who subsequently develop ILD based upon physician review of the EMR or phone interviews will be compared to the LCI scores from those scleroderma patients who did not develop ILD. Statistical analysis of LCI scores between both cohorts will determine the potential clinical utility of this non-invasive measurement of lung function in identifying those scleroderma patients who are at greatest risk for the subsequent development of ILD so treatment can be initiated early in their disease before irreversible pulmonary fibrosis develops.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Richard T Meehan, MD principal investigator
National Jewish Health
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 Scleroderma, run by National Jewish Health 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard T meehan, MD (303 3981-1475, meehanr@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Utility of Lung Clearance Index Scores at predicting Interstitial Lung disease ( ILD) development within 5 years among Scleroderma patients without ILD. (time frame: 5 years after baseline testing). 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 24 Mar 2023.