SIOPEN BIOPORTAL, an International Registry Linked to a Virtual Biobank for Patients with Peripheral Neuroblastic Tumours

Not Applicable

Recruiting

• Conditions: Ganglioneuroma; Ganglioneuroblastoma; Neuroblastoma
• 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

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Study Start: 2023-11-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2038-11-02
• Study Completion: 2038-11-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Exclusion Criteria

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