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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL168126-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of California, San Francisco | OTHER |
| University of Michigan | OTHER |
| University of Kansas |
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A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with RA-ILD | Assessments include:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research Testing Performed (Laboratory) | Genetic | Blood collection (DNA, RNA) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the role of novel quantitative imaging | Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression. | 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing peripheral blood telomere length (PB-TL) | Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD. | 5-years |
| Defining peripheral blood transcriptomic profiles |
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Inclusion Criteria:
Exclusion Criteria:
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RA-ILD study patients will be recruited from the University of Colorado Hospital, ILD Clinic (CU, PI: Joyce Lee, MD), in addition to the Rheumatology Clinic at the University of Colorado Hospital. Subjects will additionally be recruited from three unaffiliated ILD centers: University of California San Francisco (UCSF; site PI Dr. Paul Wolters), University of Kansas (KU, site PI Dr. Scott Matson), and University of Michigan (UM, site PI Dr. Justin Oldham).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haylie Lengel | Contact | 970-376-8303 | haylie.lengel@cuanschutz.edu | |
| Joyce S Lee | Contact | 303-724-6109 | joyce.lee@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joyce S Lee | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| OTHER |
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Blood will be obtained for DNA (deoxyribonucleic acid), RNA (ribonucleic acid), serum, and plasma at baseline and at 12 months for all sites. For subjects enrolled in the study at the University of Colorado, peripheral blood samples will be obtained every 3-4 months. Samples not being directly assayed will be banked for future analysis.
| Information Collected as Standard of Care |
| Diagnostic Test |
High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT) |
|
| Research Testing Performed | Other | Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires |
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Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD.
| 5-years |
| Exploring if a composite profile more accurately identifies progressive RA-ILD | Investigators will use logistic least absolute shrinkage and selection operator (LASSO) to develop a predictive model of RA-ILD progression using demographics, novel imaging, PB-TL and peripheral blood transcriptome. | 5-years |
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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| University of Kansas | Recruiting | Kansas City | Kansas | 66103 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007753 | Laboratories |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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