Collection of Biological Data With Potential Prognostic Relevance in Patients With MYELODYSPLASTIC SYNDROMES
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening
研究概览
简要总结
The present study is designed to determine the mutational status of markers (TET2 and PLCb2, cytogenetic aberrations) together with methylation status of the above genes using bone marrow and matched buccal cell samples from MDS patients who necessitate to start a treatment (i.e. EPO, Lenalidomide, Azacytidine). All patients included in the study will be followed for at least 2 years.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Patients diagnosed with MDS according to FAB, WHO and IPSS classifications
- •All clinically treatable MDS patients with EPO or Lenalidomide or 5-Azacytidine;
- •Hb < 10 g/dL
- •Age ≥ 18 years
- •Gender: Male or Female
- •Sufficient amount of biological samples for molecular studies
排除标准
- •Age <18 years
- •Patients who do not require treatment on "watch and wait" strategy
- •Insufficient amount of biological samples for molecular studies
结局指标
主要结局
Analyze the incidence of TET2 gene mutations and Validation of the prognostic potential of TET2 mutations and MPLA screening
时间窗: 2 years
Analyze the incidence of TET2 gene mutations in a series of MDS patients and describe the clinical status of patients carrying mutations Validation of the prognostic potential of TET2 mutations and MPLA screening on: * Response rate to treatment with Epo, Lenalidomide and Azacitidine * Progression Free Survival (PFS )
次要结局
- Validation of the prognostic potential of TET2 mutations(2 years)