跳至主要内容
临床试验/NCT02899039
NCT02899039已完成不适用

Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2012年7月17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
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

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

Experimental

Subjects suffering from IgG4-related disease

干预措施: extra blood draw samples (Biological)

Sjögren syndrome

Active Comparator

Subjects suffering from Sjôgren syndrome

干预措施: extra blood draw samples (Biological)

Healthy controls

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Follicular Helper T Cells: Biological Marker and... | 临床试验