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Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease

NCT06397677 · University of Colorado, Denver
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Official title
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)
About this study
The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects. Procedures performed: Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs Every 4 months (at clinic visit): Blood sample, questionnaires Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Eligibility criteria
Inclusion Criteria: * Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria * 18 years of age or older Exclusion Criteria: * Prior medication treatment specifically for RA-ILD * Inability to give informed consent * Pregnant women
Study design
Enrollment target: 450 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-01-22
Estimated completion: 2034-01
Last updated: 2024-05-03
Interventions
Genetic: Research Testing Performed (Laboratory)Diagnostic Test: Information Collected as Standard of CareOther: Research Testing Performed
Primary outcomes
  • Evaluating the role of novel quantitative imaging (5-years)
Sponsor
University of Colorado, Denver · other
With: National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, University of Michigan, University of Kansas
Contacts & investigators
ContactHaylie Lengel · contact · haylie.lengel@cuanschutz.edu · 970-376-8303
ContactJoyce S Lee · contact · joyce.lee@cuanschutz.edu · 303-724-6109
InvestigatorJoyce S Lee · principal_investigator, University of Colorado, Denver
All locations (4)
University of California San FranciscoRecruiting
San Francisco, California, United States
University of Colorado DenverRecruiting
Aurora, Colorado, United States
University of KansasRecruiting
Kansas City, Kansas, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease · TrialPath