Use of Specific Genetic Alteration s of Tumoral Cells Identified by NGS to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor -
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations
研究概览
简要总结
The search for genetic alterations in primary tumor by NGS techniques followed by the detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with metastatic and/or high risk solid tumor, of the following pathologies :
- •Neuroblastoma, sarcoma, malignant brain tumor (medulloblastoma, high-grade glioma), bone tumors, rhabdoid tumors, others rare tumors
- •Availability of a frozen tumoral sample (primary tumor or metastasis whatever the localization) at diagnosis allowing analysis of genetic alterations by a NGS technique
- •Age < 18 years
- •Signed informed consent by parents or legal representatives
- •Patient having health care insurance
- •Exclusion Criteria :
- •Age ≥ 18 years
- •No signed informed consent by parents or legal representatives
排除标准
- 未提供
结局指标
主要结局
Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations
时间窗: at the inclusion
Genetic alterations which have been previously detected by NGS technique in the tumor, in circulating tumoral DNA and/or CTC/DTC present in a blood sample at the inclusion.
Detection of specific genetic alterations of tumoral cells in peripheral samples
时间窗: Up to 6 years
Detection of specific genetic alterations of tumoral cells in peripheral samples for which presence of tumoral cells has been confirmed by conventional clinic techniques (cytology, anatomopathology, immunohistochemistry
次要结局
- Change of CTC/DTC/circulating tumoral DNA levels detected by PCR targeting specific genetic alterations of tumoral cells in peripheral samples will be confronted to clinical features including patient outcome(Up to 6 years)
- Detection of genetic alterations in solid tumor pediatric samples(At the inclusion)