Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease
NCT ID: NCT06397677
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2024-01-22
2034-01-31
Brief Summary
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The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with RA-ILD
Assessments include:
* Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test.
* Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up.
* Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide.
* High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD.
* Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year.
* Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review.
Research Testing Performed (Laboratory)
Blood collection (DNA, RNA)
Information Collected as Standard of Care
High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
Research Testing Performed
Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires
Interventions
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Research Testing Performed (Laboratory)
Blood collection (DNA, RNA)
Information Collected as Standard of Care
High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
Research Testing Performed
Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
Exclusion Criteria
* Inability to give informed consent
* Pregnant women
18 Years
90 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
University of Michigan
OTHER
University of Kansas
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Joyce S Lee
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
University of Kansas
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Paul Wolters, MD
Role: primary
Scott Matson, MD
Role: primary
Justin Oldham, MD
Role: primary
Other Identifiers
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23-0295
Identifier Type: -
Identifier Source: org_study_id
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