Developing prediction models for sarcoidosis progression
Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
University of California, San Francisco · NCT05567133
This study is trying to find out which signs and blood tests can help predict how sarcoidosis will progress in adults with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05567133 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create prediction models that assess the risk of progression in patients with pulmonary sarcoidosis. By utilizing clinical data and blood markers collected during routine clinic visits, the study seeks to identify key clinical features and biomarkers that can indicate disease evolution. The primary objective focuses on determining which clinical characteristics are associated with disease progression, while the secondary objective evaluates the potential of specific blood biomarkers to enhance risk assessment. The study will involve adults diagnosed with sarcoidosis and will follow established diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of pulmonary sarcoidosis.
Not a fit: Patients who are pregnant, breastfeeding, or have concurrent medical conditions that may affect biomarker expression will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more accurate prognostic information regarding the progression of their sarcoidosis.
How similar studies have performed: While similar studies have explored biomarkers in sarcoidosis, this approach of integrating clinical data with novel blood markers is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults with a diagnosis of sarcoidosis over the age of 18 2. Case definition: we will follow the 1999 statement on sarcoidosis published by the American Thoracic Society for diagnosis which includes tissue biopsy confirmation and exclusion of alternative diagnoses including beryllium sensitization/chronic beryllium disease, mycobacterial, viral, and/or fungal infection Exclusion Criteria: 1. Inability to tolerate study procedures as determined by the investigator 2. Pregnant or breastfeeding 3. Concurrent medical diagnoses that would influence the expression of biomarkers will be considered an exclusion criterion. This includes diseases such as common variable immunodeficiency, HIV infection, or autoimmune diseases 4. Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis 5. Hematocrit (Packed Cell Volume) \< 25%
Where this trial is running
Baltimore, Maryland and 1 other locations
- University of Maryland — Baltimore, Maryland, United States (RECRUITING)
- UT Southwestern — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Laura Koth — University of California, San Francisco
- Study coordinator: Laura Koth
- Email: laura.koth@ucsf.edu
- Phone: 4155144369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcoidosis, Pulmonary, sarcoid, lung, immune