SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention NA.
- Who it may be relevant to
- Registry conditions: Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia, France, Norway, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other No Intervention NA
Additional blood sampling (not mandatory)
Primary outcome measures
- Rate of patients having their clinical data registered [Time frame: 6 months]
- Rate of patients for whom information on biological samples/material is collected [Time frame: 6 months]
Secondary outcome measures (2)
- Progression-free survival (PFS) [Time frame: 12 months]
- Overall-survival (OS) [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
I-1. Patients with PNT: ganglioneuroma or ganglioneuroblastoma or neuroblastoma, I-2. At the time of initial diagnosis of neuroblastic tumour, or at relapse/progression if not yet registered I-3. Written patient informed consent, or parents or legal representative written informed consent and assent of the child, adolescent or young adult
Non-Inclusion Criteria:
R-1. (Adult) Patients with olfactory neuroblastoma R-2. Central nervous system (CNS) neuroblastoma (as per the WHO classification)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 27 centers
- CHU Amiens — Amiens
- Chu Angers — Angers
- Hôpital Jean Minjoz — Besançon
- Hôpital des enfants — Bordeaux
- Chru Brest — Brest
- CHU CAEN - Fédération de cancérologie - niveau 21 — Caen
- CHU D'Estaing de CLERMONT FERRAND — Clermont-Ferrand
- DIJON Hôpital d'enfants — Dijon
- … and 19 more centers
Switzerland · 9 centers
- Kantonsspital Aarau AG — Aarau
- Universitäts-Kinderspital beider Basel UKBB — Basel
- Ospedale San Giovanni — Bellinzona
- Inselspital Bern — Bern
- HUG Hôpitaux Universitaires Genève — Geneva
- CHUV, Centre hospitalier universitaire vaudois — Lausanne
- Kinderspital Zentralschweiz, Luzern — Lucerne
- Ostschweizer Kinderspital — Sankt Gallen
- … and 1 more center
Czechia · 1 center
- Fakultni nemocnice v Motole — Prague
Norway · 1 center
- Oslo Universitetssykehus — Oslo
Identifiers
NCT: NCT05192980 · IC 2020-17