Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease (ACG et TREG)
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.
The study is classified interventional because a lot of blood samples are taken.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dijon、法国、21079
- Centre Hospitalier Universitaire
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients
- Patients who have provided written consent
- Patients with national health insurance cover
- Age > 50 years
- Patients with a diagnosis of Horton's disease, before any treatment
Horton's disease is defined by the American College Rheumatology ACR criteria [2], as the association of 3 of the following 5 criteria:
- age at disease onset 50 years or older
- recent onset localized headache
- indurated temporal artery or diminished/abolition of temporal pulse
- erythrocyte sedimentation rate (ESR) greater than 50 mm during the first hour (or C Reactive protein (CRP)>20 mg/L)
- Positive temporal artery biopsy (TAB) showing vascularitis with infiltration by mononuclear cells or granulomatous inflammation with or without giant cells.
Control subjects
Control subjects will be healthy volunteers recruited among blood donors at Dijon University Hospital, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious, inflammatory or auto-immune diseases or cancer (CRP<5mg/L) recruited in the investigating departments of Dijon Hospital. They will be matched for age and sex and must meet the following criteria:
- Age > 50 years
- Patients with national health insurance cover
- Signed written informed consent form
- Absence of an inflammatory syndrome (CRP<5 mg /L)
Exclusion Criteria:
- Adult under guardianship
- Persons without national health insurance cover
- Pregnant or breast-feeding women
- Patients treated with corticoids or immunosuppressants in the month preceding inclusion
- Patients treated with chemotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Measurement by flow cytometry of the percentage of CD39+ Treg (CD4+CD25highFoxP3+CD39+) among total CD4 TL
大体时间：through study completion an average of 30 months
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through study completion an average of 30 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
血液样本的临床试验
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Centre Hospitalier Universitaire de Saint Etienne完全的