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临床试验/NCT01066338
NCT01066338
Unknown
不适用

Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 500 人2010年2月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Myeloid Leukemia
发起方
Samsung Medical Center
入组人数
500
试验地点
1
主要终点
overall response rate
最后更新
16年前

概览

简要总结

The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.

The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.

The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.

注册库
clinicaltrials.gov
开始日期
2010年2月
结束日期
待定
最后更新
16年前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • patients with normal karyotype acute myeloid leukemia
  • 18 years or older
  • patients were treated with standard chemotherapy
  • patients with available medical record and stored bone marrow specimen at time of diagnosis

排除标准

  • no definitive criteria

结局指标

主要结局

overall response rate

时间窗: within 1 month after enrollment

次要结局

  • overall survival time(within 1 month after enrollment)

研究点 (1)

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