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临床试验/NCT05076071
NCT05076071Unknown不适用

Clinical Value of Next Generation Sequencing in Chinese Childhood Solid Tumors: A Multicenter Study

Yizhuo Zhang1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年8月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Mutation characteristics of malignant solid tumors in Chinese children.

研究概览

简要总结

Samples of 200 patients with pediatric malignant solid tumors will prospectively be collected. Selected samples are sufficient for next generation sequencing(NGS) and available for follow-up information. Multi-omics techniques such as DNA and RNA panel will be used to study driver genes for the development of malignant solid tumors in children, and to explore the pathogenic mechanism. The aim of this study is to explore new biomarkers for the diagnosis and treatment for childhood malignant solid tumors.

详细描述

DNA and RNA extracted from tumor tissues and leukocytes will be analyzed by Onco PanScan/whole exon sequencing(Genetronhealth), and comprehensive gene mutation information such as single nucleotide variation, insertion deletion mutation, gene copy number variants and structure variants will be obtained.

Through in-depth mining of genomic data generated by clinical tumor tissue detection, the differences among different subtypes of pediatric solid tumors in TCGA data will be compared with previous studies. Combined with clinical pathological and molecular subtyping results, auxiliary diagnosis was performed. Analyzing therapeutic targets and identifying pathogenic cancer-predisposing variants may provide molecular reference for children's malignant solid tumors.

研究设计

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

入排标准

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

入选标准

  • Patients are diagnosed by histology and pathology as pediatric malignant solid tumors (including soft tissue sarcoma, osteosarcoma, pediatric glioma, neuroblastoma, nephroblastoma, retinoblastoma, hepatoblastoma, atypical teratoid/rhabdomymoma, embryonal tumor, etc.);
  • Age: < 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) PS score: 0-2, estimated survival >6 months;
  • Complete clinical laboratory examination and pathological examination information of patients;
  • Patients can be evaluated on time, and samples can be obtained throughout the whole test process;
  • Informed consent signed by the patient or his/her legal representative shall be obtained after the patient is informed of the project;

排除标准

  • As determined by the investigator, the patient had other major diseases that might affect follow-up and short-term survival;
  • Any social/psychological problems that the researcher determines are not suitable for the study;

结局指标

主要结局

Mutation characteristics of malignant solid tumors in Chinese children.

时间窗: 2021.8-2023.8

次要结局

未报告次要终点

研究者

发起方
Yizhuo Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yizhuo Zhang

proffesor

Sun Yat-sen University

研究点 (1)

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