RECRUITING

Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Lung Clearance Measurement to Determine Pre-clinical Airway Involvement in Scleroderma Patients Without Lung Disease as a Risk Factor for Developing ILD

Quick Facts

Study Start:2021-01-04
Study Completion:2026-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04535245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of systemic sclerosis (SSC) by an NJH Rheumatologist
  2. * age 21-75
  3. * No evidence of Scleroderma related Lung disease (ILD)
  4. * Able to comprehend and sign an Institutional Review Board (IRB) approved consent form.
  1. * Patients without a Rheumatologists confirming a diagnosis (DX) of SSC
  2. * 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% .
  3. * Cardiac echocardiogram or right heart catheter evidence of Pulmonary Arterial Hypertension (PAH).
  4. * \< 21 or \> 75 years of age
  5. * Must not be pregnant or had eye surgery within 2 weeks of LCI testing
  6. * Must be able to comprehend and sign an IRB approved consent form and complete LCI testing

Contacts and Locations

Study Contact

Richard T meehan, MD
CONTACT
303 3981-1475
meehanr@njhealth.org
Mary Gill, RN
CONTACT
720 936-9619
gillm@njhealth.org

Principal Investigator

Richard T Meehan, MD
PRINCIPAL_INVESTIGATOR
National Jewish Health

Study Locations (Sites)

National Jewish Health
Denver, Colorado, 80206
United States

Collaborators and Investigators

Sponsor: National Jewish Health

  • Richard T Meehan, MD, PRINCIPAL_INVESTIGATOR, National Jewish Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-04
Study Completion Date2026-01-15

Study Record Updates

Study Start Date2021-01-04
Study Completion Date2026-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Scleroderma