Immunologiska Mekanismer Vid Sarkoidos
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Disease activity
研究概览
简要总结
There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Cardiac sarcoidosis can lead to life threatening arrythmias and calcium metabolism disturbances can lead to renal impairment.
Treatment with different forms of immunosuppressants are usually tried to dampen symptoms but are not effective in all patients. Furthermore, the disease usually flares up after cessation of treatment. The variability in diseae course and treatment response is thought, at least to some degree, to be explained by individual differences in genetics, immune cells and signaling pathways. But existing evidence is limited. In other inflammatory diseases the gut microbiome is of importance for disease course but its role in sarcoidosis has not been clarified.
In this prospective project the investigators will study genes, inflammatory cells and signaling molecules in the lung, upper airways and blood, and to some extent microbes, also in faeces. Healthy volunteers will be included for comparative studies. Most samples will be taken during normal diagnostic work-up and follow-up of patients with/with suspected sarcoidosis. The findings will be correlated to disease course and effects of different treatments. By linking to national health data and demographic registries, comorbidities and environmental factors will be correlated to data.
By this, the investigators hope to improve understanding of which genes, cells and signaling molecules that are of importance for resolving vs non-resolving disease and why some patients respond to a certain treatment and others don´t. The overall goal is to assess and predict sarcoidosis outcomes. We hypothesize that blood-based biomarkers including those taken during routine care as well as novel cell, signaling molecules and genetic markers, in combination with clinical characteristics can be used to predict outcomes, also treatment response, in sarcoidosis. The results can lead to tailored treatment and individual follow-up for each patient with sarcoidosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suspicion of sarcoidosis
- •Swedish speaking
- •Able to understand and approve of study protocol
- •No contraindications for planned interventions
- •For inclusion of healthy controls they need to be healthy and the same criteria as listed above for patients.
排除标准
- •No suspicion of sarcoidosis
- •Not Swedish-speaking
- •Not able to understand study protocol
- •Not approving of study protocol
- •Contraindications for planned interventions
研究组 & 干预措施
Sarcoidosis patients
This study only consists of one arm. The investigators follow patients prospectively and observe clinical parameters including disease course (resolving, non-resolving, which organs are involved, inflammatory markers, chest X-ray etc) and effect of treatment. In this respect the study is observational. However, the patients undergo repeated peripheral blood samples and some also undergo sampling from upper airways, faeces and a bronchoscopy and hence, the study falls in the interventional category
干预措施: peripheral blood sampling, bronchoscopy, upper airway and faeces sampling (Procedure)
结局指标
主要结局
Disease activity
时间窗: 3 months and 12 months
This refers to cardiac sarcoidosis and is estimated with PET-CT
Number of participants with resolving vs non-resolving disease
时间窗: 2 and 5 years from baseline
Data will be collected from the medical record wether the disease resolved or not
Number of participants with immunosuppressive treatment
时间窗: 5 years
Data on treatment will be collected from the medical record
Number of participants with more than 10% change from enrollment in percent of predicted Forced Expiratory Volume in one second (L/s) at 5 years
时间窗: Baseline and 5 years
Measured with spirometry
Change from enrollment in Immunoglobulin G (g/L) at 5 years
时间窗: Baseline and 5 years
Measured in serum
Change from enrollment in fatigue at 5 years
时间窗: Baseline and 5 years
The Fatigue Assessment Scale will be used. Maximum score is 50 and minimum 10. A higher score means more fatigue.More than 22 points means the participant suffers from fatigue and more than 34 extreme fatigue.
Change from enrollment of radiographic findings at 5 years
时间窗: Baseline and 5 years
Chest X-ray will be classified according to Scadding staging
Change from enrollment of angiotensin converting enzyme (E/L) at 5 years
时间窗: Baseline and 5 years
Measured in serum
Change from enrollment of soluble Interleukin Receptor 2 (U/ml) at 5 years
时间窗: Baseline and 5 years
Measured in serum
Change from enrollment of complete blood cell count (/10x9 L) at 5 years
时间窗: Baseline and 5 years
Measured in blood
Change from enrollment of creatinine levels (micromol/L) at 5 years
时间窗: Baseline and 5 years
Measured in plasma
Change from enrollment of C-reactive protein (mg/L) at 5 years
时间窗: Baseline and 5 years
Measured in serum
Number of patients with more than 10% change from enrollment in percent of predicted Diffusing capacity of the Lungs for Carbon Monoxide (%) at 5 years
时间窗: Baseline and 5 years
Measured with spirometry
Number of participants with more than 10% change from enrollment in percent of predicted Forced Vital Capacity (L) at 5 years
时间窗: Baseline and 5 years
Measured with spirometry
Change from enrollment of calcium levels (mmol/L) at 5 years
时间窗: Baseline and 5 years
Measured in serum
次要结局
未报告次要终点