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临床试验/NCT04770922
NCT04770922已完成不适用

Pharmacogenomic Analysis of 6-mercaptopurine in Pediatric Acute Lymphoblastic Leukemia

Cipherome, Inc.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Novel genetic variants impact on 6-mercaptopurine adverse drug reactions

研究概览

简要总结

This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

详细描述

The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric acute lymphoblastic leukemia (ALL) subjects
  • Received 6-mercaptopurine
  • Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted
  • White blood cell (WBC) levels

排除标准

  • Pediatric ALL subjects who did NOT receive 6-mercaptopurine
  • No biobank sample
  • No WBC level

结局指标

主要结局

Novel genetic variants impact on 6-mercaptopurine adverse drug reactions

时间窗: 1 year

Objective is to clinically validate the presence of novel genetic variants and its impact on adverse drug reactions in a population of pediatric ALL patients treated with 6-MP

次要结局

  • Evaluating relationship of genetic variants to ancestry(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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