Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- blood level T cell in ITP patients and in healthy controls
研究概览
简要总结
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.
The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
- •persons who have provided written informed consent
排除标准
- •persons without national health insurance
- •persons under 18 years old
- •patients under guardianship
- •pregnancy
- •subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
结局指标
主要结局
blood level T cell in ITP patients and in healthy controls
时间窗: baseline
blood level T cell in ITP patients after treatments
时间窗: change from baseline at 4 to 8 weeks
次要结局
- blood level splenic T cell in ITP patients and in healthy controls(baseline)
- frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls(through study completion, an average of 3 years)
- level of T follicular helper cell(through study completion, an average of 3 years)