Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparison of ECP concentrations in supernatants of eosinophils culture
研究概览
简要总结
Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.
详细描述
it will assess the activation state of blood eosinophils in SSc patients compared to healthy controls (ECP production in vitro, surface activation markers, whole transcriptome array, ..).
it will also study skin eosinophils and their recruitment (extracellular eosinophil granules, eotaxins production in skin, ..)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For SSc patients:
- •Meeting the 2013 ACR-EULAR criteria for diffuse SSc (n = 20) and limited SSc (n = 20)
- •Having signed the informed consent
- •Eosinophils ≥ 0.1 G / L on the last blood test (<3 months)
- •For healthy subjects:
- •Without chronic pathology requiring long-term treatment
- •Eosinophils between 0.1 and 0.4 G / L on recent blood test (<3 months)
- •Exclusion Criteria for patients and controls:
- •Patient with an infection, state of emergency or progressive neoplastic pathology
- •Pregnant or lactating women
- •History of atopy (allergic asthma, atopic eczema, allergic rhinitis, allergic conjunctivitis)
- •Allergy to local anesthetics (for scleroderma patients only)
- •Taking into account a minimum weight of 50 kg and in the absence of cardiorespiratory effects of scleroderma, only patients with at least 10 g of hemoglobin will be included
排除标准
- 未提供
结局指标
主要结局
Comparison of ECP concentrations in supernatants of eosinophils culture
时间窗: Baseline: one session
Eosinophils will be sorted, stimulated in vitro for 2 hours and ECP concentration will be assessed in supernatants
次要结局
- In skin biopsies: density of eosinophils, extracellular ECP and MBP deposits (absent in healthy skin), and density of eotaxin-1-producing cells will be assessed in damaged skin and apparently healthy skin of SSc patients(Baseline: one session)
- Comparison of median fluorescence intensities of several surface markers on blood eosinophils, or comparison of percentages of positive cells among all eosinophils for a given marker (flow cytometry)(Baseline: one session)
- Gene expression profiles will be compared between SSc patients and healthy controls (whole transcriptome assay)(Baseline: one session)