Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

NCT04535245 | Unknown

• 1 other identifier: HS 3471
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years after baseline testing

Study Arms (1)

LCI testing

LCI testing will be performed on all study subjects

Diagnostic Test: LCI testing

Interventions

LCI testing DIAGNOSTIC_TEST

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

Also known as: no drugs will be administered

LCI testing

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Scleroderma patients without lung disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Richard T Meehan, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard T meehan, MD

CONTACT

303 3981-1475; meehanr@njhealth.org

Mary Gill, RN

CONTACT

720 936-9619; gillm@njhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor of Medicine

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: September 1, 2020
• Study Start: January 4, 2021
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)