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临床试验/NCT06116318
NCT06116318撤回不适用

Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study

Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
50
试验地点
1
主要终点
CIR

研究概览

简要总结

C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.

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
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.

排除标准

  • Patients with other factors which were considered unsuitable to participate in the study by the investigators

结局指标

主要结局

CIR

时间窗: Within 5 years after treatment

cumulative incidence of recurrence

次要结局

  • OS(Within 5 years after treatment)
  • RFS(Within 5 years after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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