SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
BIOPORTAL
1 other identifier
interventional
600
4 countries
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedStudy Start
First participant enrolled
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 2, 2038
July 22, 2025
July 1, 2025
15 years
December 13, 2021
July 17, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of patients having their clinical data registered
Registry Outcome: Rate of patients having their clinical data registered throughout their treatment and follow-up from the total of patients registered
6 months
Rate of patients for whom information on biological samples/material is collected
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
6 months
Secondary Outcomes (2)
Progression-free survival (PFS)
12 months
Overall-survival (OS)
12 months
Study Arms (1)
Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)
OTHERInterventions
Additional blood sampling (not mandatory)
Eligibility Criteria
You may qualify if:
- 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
- R-1. (Adult) Patients with olfactory neuroblastoma R-2. Central nervous system (CNS) neuroblastoma (as per the WHO classification)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (38)
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
CHU Amiens
Amiens, 80054, France
Chu Angers
Angers, 49033, France
Hôpital Jean Minjoz
Besançon, 25030, France
Hôpital des enfants
Bordeaux, 33076, France
Chru Brest
Brest, 29609, France
CHU CAEN - Fédération de cancérologie - niveau 21
Caen, 14033, France
CHU D'Estaing de CLERMONT FERRAND
Clermont-Ferrand, 63003, France
DIJON Hôpital d'enfants
Dijon, 21079, France
Chu Grenoble
Grenoble, 38045, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital d'Enfants de la Timone
Marseille, 13385, France
Hôpital Arnaud de Villeneuve
Montpellier, 34295, France
Chr Nantes
Nantes, 44093, France
CHU NICE
Nice, 06202, France
Institut Curie
Paris, 750248, France
Hôpital Armand Trousseau
Paris, 75571, France
Hôpital Jean Bernard
Poitiers, 86021, France
Chu Reims
Reims, 51092, France
Chu Hopital Sud
Rennes, 35056, France
Hôpital Charles NICOLLE
Rouen, 76031, France
Hôpital Nord
Saint-Etienne, 42055, France
Hôpital Hautepierre-CHU Strasbourg
Strasbourg, 67098, France
Hôpital des Enfants
Toulouse, 70034, France
Hôpital Clocheville
Tours, 37044, France
CHU NANCY- Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500, France
Institut Gustave Roussy
Villejuif, 94800, France
Oslo Universitetssykehus
Oslo, 0424, Norway
Kantonsspital Aarau AG
Aarau, 5001, Switzerland
Universitäts-Kinderspital beider Basel UKBB
Basel, 4056, Switzerland
Ospedale San Giovanni
Bellinzona, 6500, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
HUG Hôpitaux Universitaires Genève
Geneva, 1205, Switzerland
CHUV, Centre hospitalier universitaire vaudois
Lausanne, 1011, Switzerland
Kinderspital Zentralschweiz, Luzern
Lucerne, 6000, Switzerland
Ostschweizer Kinderspital
Sankt Gallen, 9006, Switzerland
Universitäts-Kinderspital Zürich
Zurich, 8091, Switzerland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2021
First Posted
January 14, 2022
Study Start
November 2, 2023
Primary Completion (Estimated)
November 2, 2038
Study Completion (Estimated)
November 2, 2038
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL