NCT00499070已完成不适用
TCR Vbeta Repertoire and PNH Clones in Children With Refractory Cytopenia (RC). An Open Nonrandomised Multi-Center Prospective Study
University Hospital Freiburg10 个研究点 分布在 10 个国家目标入组 119 人开始时间: 2007年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 10
- 主要终点
- Number of patients with TCR V beta oligoclonality at diagnosis
研究概览
简要总结
RATIONALE: Studying biopsy, bone marrow, and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment.
PURPOSE: This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment.
详细描述
OBJECTIVES:
Primary
- To evaluate the value of TCR V beta repertoire analysis for the determination of autoimmunity in refractory cytopenia (RC).
- To evaluate which immunophenotypic hematopoietic subclones are associated with oligoclonal T-cell expansion in RC.
- To evaluate the presence of paroxysmal nocturnal hemoglobinuria (PNH) clones in RC.
Secondary
- To compare the molecular response with the hematologic response in patients with RC after treatment with immunosuppressive therapy (IST).
- To compare the molecular response with human leukocyte histocompatability antigen (HLA) expression in patients with RC after treatment with IST.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of patients with TCR V beta oligoclonality at diagnosis
时间窗: 96 months
Immunophenotype of patients with oligoclonal T-cell expansion
时间窗: 96 months
Number of patients with glycophosphatidylinositol (GPI) deficient clones
时间窗: 96 months
次要结局
- Number of patients with HLA-DR15 antigen expression and molecular response as compared to number of patients with other HLA-DR antigens and molecular response(96 months)
- Number of patients with molecular response as compared to hematological response after IST(96 months)
- Overall survival(96 months)
- Failure-free survival(96 months)
研究者
Charlotte Niemeyer, MD
MD Prof. Dr. med. Niemeyer
University Hospital Freiburg
研究点 (10)
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