Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 54
- 主要终点
- Progression-Free survival
研究概览
简要总结
Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification.
This protocol deals with a prospective analysis of the genomic profile established by CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in France, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. The objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment.
详细描述
After diagnosis of Neuroblastoma (NB) or Ganglioneuroblastoma :
- Frozen tumor sample (cell content ≥60%) must be sent for genomic profile determination by CGH-array,
- Blood sample at diagnosis must be sent to evaluate MYCN amplification in plasma,
- In case of NB with a MYCN amplification, blood sample during treatment and follow-up must be sent.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neuroblastoma or Ganglioneuroblastoma defined by INSS criteria (Brodeur et al. 1993)
- •Age < 18 years
- •Availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60%
- •Inclusion in 4 months following the diagnosis
- •All patients treated in French centers (SFCE) for Neuroblastic tumour, including those participate in national or international protocols.
- •Written informed consent
- •Patients with French Social Security in compliance with the French law relating to biomedical research.
排除标准
- •Chemotherapy or radiotherapy before taking tumour samples
- •Refusal of the parents or the legal representatives
结局指标
主要结局
Progression-Free survival
时间窗: 3 years
Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.
次要结局
- Overall-Free survival(3 years)
- Progression at metastatic location-Free survival(3 years)