SIOPEN BIOPORTAL, an International Registry Linked to a Virtual Biobank for Patients with Peripheral Neuroblastic Tumours
- Conditions
- GanglioneuromaGanglioneuroblastomaNeuroblastoma
- Interventions
- Other: No Intervention NA
- Registration Number
- NCT05192980
- Lead Sponsor
- Institut Curie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma) No Intervention NA -
- Primary Outcome Measures
Name Time Method Rate of patients for whom information on biological samples/material is collected 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 6 months Registry Outcome: Rate of patients having their clinical data registered throughout their treatment and follow-up from the total of patients registered
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 12 months Investigation of the impact of the variables currently used for assignment to risk groups and treatment stratification (MYCN Status, ALK Status, stage, age, primary tumor site) on progression-free survival (PFS) using the Kaplan-Meier method
Overall-survival (OS) 12 months Investigation of the impact of the variables currently used for assignment to risk groups and treatment stratification (MYCN Status, ALK Status, stage, age, primary tumor site) on overall-survival (OS) using the Kaplan-Meier method
Trial Locations
- Locations (27)
CHU Amiens
🇫🇷Amiens, France
Centre Oscar Lambret
🇫🇷Lille, France
Chu Angers
🇫🇷Angers, France
Hôpital Jean Minjoz
🇫🇷Besançon, France
Hôpital des enfants
🇫🇷Bordeaux, France
Chru Brest
🇫🇷Brest, France
CHU CAEN - Fédération de cancérologie - niveau 21
🇫🇷Caen, France
CHU D'Estaing de CLERMONT FERRAND
🇫🇷Clermont-Ferrand, France
DIJON Hôpital d'enfants
🇫🇷Dijon, France
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, France
Chu Grenoble
🇫🇷Grenoble, France
Hôpital Jean Bernard
🇫🇷Poitiers, France
Centre Léon Bérard
🇫🇷Lyon, France
Hôpital d'Enfants de la Timone
🇫🇷Marseille, France
Chr Nantes
🇫🇷Nantes, France
CHU NICE
🇫🇷Nice, France
Institut Curie
🇫🇷Paris, France
Hôpital Armand Trousseau
🇫🇷Paris, France
Chu Reims
🇫🇷Reims, France
Chu Hopital Sud
🇫🇷Rennes, France
Hôpital Charles NICOLLE
🇫🇷Rouen, France
Hôpital Nord
🇫🇷Saint-Étienne, France
Hôpital Hautepierre-CHU Strasbourg
🇫🇷Strasbourg, France
Hôpital des Enfants
🇫🇷Toulouse, France
Hôpital Clocheville
🇫🇷Tours, France
CHU NANCY- Hôpital d'Enfants
🇫🇷Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France