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临床试验/NCT03537105
NCT03537105已完成不适用

Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Skin IL-34 mRNA expression levels

研究概览

简要总结

By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.

详细描述

The mechanisms involved in the physiopathology of systemic sclerosis (SSc) are not fully understood, particularly the pattern of cytokine expression in the skin of SSc patients. These cytokines are known to play a central role in the regulation of numerous inflammatory diseases and, among them, IL-34 is the only cytokine which has been found to be down-regulated in other skin inflammatory disorders such psoriasis or atopic dermatitis. IL-34 has been described as an immunosuppressive cytokine, and our preliminary results show that IL-34 is active on fibroblasts, a key cell that undergoes dysfunction in SSc. Thus, we are willing to explore its expression profile in the skin of SSc patients and its potential role in the physiopathology of the disease. For this study, we will analyze IL-34 mRNA levels in the skin and the plasma of SSc patients by comparison to healthy patients. Thirty patients will be included in the Internal Medicine Unit of the CHU de Poitiers during a single visit, in the frame of their medical follow-up, to collect two skin biopsies and 5 ml of blood after obtaining their informed consent. The expression of IL-34 will also be investigated at the protein level by immunostaining on skin sections and by ELISA (skin protein lysates and plasma). Moreover, the expression of other proinflammatory cytokines will be investigated both at the mRNA and protein levels.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 year-old
  • •Diagnosis of systemic sclerosis according to ACR/EURAL 2013 criteria.
  • •Skin sclerosis reaching an area over finger bases of hands and feet
  • •Free subject, without neither guardianship, wardship nor subordination
  • •Patient with Social Security
  • •Informed and signed consent by the patient after clear and loyal information on the study

排除标准

  • •Age < 18 year-old
  • •Patients that do not fit the ACR/EURAL 2013 criteria
  • •Patients under immunosuppressive treatment
  • •Sclerosis limited to fingers of hands and feets.
  • •Patient without Social Security
  • •Pregnant and nursing women

研究组 & 干预措施

Sclerodermic patients

Experimental

Sclerodermic patients presenting cutaneous fibrosis

干预措施: Skin biopsies (Procedure)

结局指标

主要结局

Skin IL-34 mRNA expression levels

时间窗: 1 day

Skin IL-34 mRNA expression levels (expressed in % of relative expression of GAPDH) in systemic sclerosis patients by comparison with healthy subjects. Skin biopsies are collected at D0 for SSc patients (inclusion day)

次要结局

  • Immunostainings against IL-34 and other cytokines on skin sections(1 day)
  • Protein expression levels of IL-34 and other cytokines by ELISA(1 day)
  • Skin IL-34 mRNA expression levels of other cytokines(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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