SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 76
- 主要终点
- Rate of patients for whom information on biological samples/material is collected
研究概览
简要总结
The SIOPEN BIOPORTAL is a prospective non-therapeutic multi-centre international study aimed at developing an international Registry linked to a Virtual Biobank for all the patients with peripheral neuroblastic tumor within countries of the SIOPEN network. The overall aim of this study is to provide a GDPR-compliant framework to collect basic clinical annotations, biological and genetic features and information about the location on biospecimens for all the patients with a peripheral neuroblastic tumor including neuroblastoma, ganglioneuroblastoma and ganglioneuroma in the SIOPEN network.
This study will support data and sample management and intensify cross-borders data and sample sharing fostering translational and clinical research. The post-hoc hypothesis formulated based on the data generated in this study will be used as statistical basis for future precision medicine programs based on improved biological characterization, patient stratification and therapeutic management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PNT: ganglioneuroma or ganglioneuroblastoma or neuroblastoma, I-
- •At the time of initial diagnosis of neuroblastic tumour, or at relapse/progression if not yet registered I-
- •Written patient informed consent, or parents or legal representative written informed consent and assent of the child, adolescent or young adult
- •Non-Inclusion Criteria:
- •(Adult) Patients with olfactory neuroblastoma R-
- •Central nervous system (CNS) neuroblastoma (as per the WHO classification)
排除标准
- 未提供
结局指标
主要结局
Rate of patients for whom information on biological samples/material is collected
时间窗: 6 months
Virtual Biobank Outcome: Rate of patients for whom information on biological samples/material collected and stored in SIOPEN is available from the total of patients registered
Rate of patients having their clinical data registered
时间窗: 6 months
Registry Outcome: Rate of patients having their clinical data registered throughout their treatment and follow-up from the total of patients registered
次要结局
- Progression-free survival (PFS)(12 months)
- Overall-survival (OS)(12 months)