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临床试验/NCT03715621
NCT03715621Unknown不适用

A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
1-year relapse rate after allo-HSCT

研究概览

简要总结

Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.

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

入选标准

  • 18 years or old;
  • Clinical diagnosis of acute myeloid leukemia (AML);
  • Availabe records of MICM and NGS results at diagnosis;
  • Be going to receive allo-HSCT.

排除标准

  • Active malignancy;
  • Pregnant or breast feeding women.

结局指标

主要结局

1-year relapse rate after allo-HSCT

时间窗: 1 year after allo-HSCT

1-year relapse rate after allo-HSCT

次要结局

  • 1-year recurrence-free survival (RFS)(1 year after allo-HSCT)
  • 1-year overall survival (OS)(1 year after allo-HSCT)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Depei

professor

The First Affiliated Hospital of Soochow University

研究点 (1)

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