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临床试验/NCT04274231
NCT04274231Unknown不适用

Integrative Genomic Analysis Reveals Cancer-associated Gene Mutations in Chronic Myeloid Leukemia Patients With Tyrosine Kinase Inhibitor Resistance or Intolerance

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
cancer-associated gene mutations in CML treatment with TKIs by NGS

研究概览

简要总结

We performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs by next-generation sequencing (NGS) .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic myeloid leukemia-Chronic phase(CML-CP) patients treated with receiveTyrosine kinase inhibitor -TKI(including imatinib, dasatinib and nilotinib) for more than 1 years
  • best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs according to Q-pcr detected BCR/ABL(IS) in peripheral blood and hematologic response and cytogenetic response
  • Informed consent of the patient or his legal representative

排除标准

  • Patients had history of CML-AP or CML-BC
  • CML Patients who have received allogeneic hematopoietic stem cell transplantation
  • CML Patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy)
  • Woman who is pregnant or nursing

结局指标

主要结局

cancer-associated gene mutations in CML treatment with TKIs by NGS

时间窗: 1 year after TKI treatment

We performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to TKIs ,or intolerance to TKIs,or resistance to TKIs by next-generation sequencing (NGS)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

xuna

doctor

Nanfang Hospital, Southern Medical University

研究点 (1)

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