Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Mean Change in Forced Vital Capacity in Liters
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
结局指标
主要结局
Mean Change in Forced Vital Capacity in Liters
时间窗: Baseline and 24 months
Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver.
次要结局
未报告次要终点