Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 32
- 主要终点
- Correlate pharmacogenetic analysis with veno-occlusive disease.
研究概览
简要总结
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.
The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.
详细描述
Case-control study, nested in two French multicenter cohorts, on pharmacognenetic, biological and clinical susceptibility factors associated with the occurrence of hepatic veno-occlusive disease during the anticancer treatment for nephroblastoma or acute lymphoblastic leukemia, with centralized genetic analysis.
After obtaining consent (patient or parents for minor patients), a blood sample is collected during the routine follow-up consultation and tubes are sent directly to Paris for the pharmacogenetic analysis at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged < 18 years old at the time of cancer diagnosis
- •Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation
- •Weight greater than 5 kg at inclusion
- •Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
- •Affiliated to a Social Security scheme
排除标准
- •Unavaibility of constitutional DNA
- •Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence
- •Pregnant, lactating or parturient women
- •Person deprived of their liberty by judicial or administrative decision
- •Person under psychiatric care under duress
- •Person subject to legal protection
- •Person unable to express their consent
研究组 & 干预措施
Nephrobalstoma or ALL
Pateints treated for a nephrobalstoma or ALL in childhood or adolescence
干预措施: Blood test for genetic analysis (Other)
结局指标
主要结局
Correlate pharmacogenetic analysis with veno-occlusive disease.
时间窗: One day
Illumina's "Human Omni2.5-8 v1.3" microarrays explore more than 2,600,000 genetic variants, thus covering the entire genome with more than 300,000 genetic biomarkers in exons.
次要结局
- Participant characteristics.(One day)