Risk Indicators of Sarcoidosis Evolution-Unified Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sarcoidosis, Pulmonary. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
Overview
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.
Detailed description
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.
Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.
Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.
The investigators will measure two types of blood markers to achieve this goal:
* Clinically available blood markers that are available in most clinical labs * Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs
Primary outcome measures
- Mean Change in Forced Vital Capacity in Liters [Time frame: Baseline and 24 months]
Eligibility criteria
Inclusion criteria
- Adults with a diagnosis of sarcoidosis over the age of 18
- 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
- Inability to tolerate study procedures as determined by the investigator
- Pregnant or breastfeeding
- 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
- Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis
- Hematocrit (Packed Cell Volume) < 25%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- University of Maryland — Baltimore
- UT Southwestern — Dallas
Publications
- Drake WP, Hsia C, Samavati L, Yu M, Cardenas J, Gianella FG, Boscardin J, Koth LL. Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP): protocol for a multi-centre, longitudinal, observational study to identify clinical features that are predictive of sarcoidosis progression. BMJ Open. 2023 Apr 3;13(4):e071607. doi: 10.1136/bmjopen-2023-071607. PMID 37012011
Identifiers
NCT: NCT05567133 · P0551258 · R01HL157533