Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
研究概览
简要总结
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.
The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.
These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.
The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.
The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •IgG4-related disease patients or
- •Sjogren syndrome patients or
- •Healthy subjects
排除标准
- •Presence of autoimmune or inflammatory associated disease
- •Age less than 18 years
研究组 & 干预措施
IgG4-related disease
Subjects suffering from IgG4-related disease
干预措施: extra blood draw samples (Biological)
Sjögren syndrome
Subjects suffering from Sjôgren syndrome
干预措施: extra blood draw samples (Biological)
Healthy controls
Healthy subjects
干预措施: extra blood draw samples (Biological)
结局指标
主要结局
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
时间窗: 36 months
次要结局
未报告次要终点
