SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours

Neuroblastoma Clinical Trial

— BIOPORTAL  

Official title:

SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192980
• Other study ID #: IC 2020-17
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: November 2, 2038

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Gudrun Schleiermacher, MD,PhD
• Phone: 0144324554
• Email: gudrun.schleiermacher[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2, 2038
• Est. primary completion date: November 2, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Ganglioneuroblastoma
• Ganglioneuroma
• Neuroblastoma

Intervention

Other:
• No Intervention NA
Additional blood sampling (not mandatory)

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
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	Chu Grenoble	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Hôpital d'Enfants de la Timone	Marseille
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Chr Nantes	Nantes
France	CHU NICE	Nice
France	Hôpital Armand Trousseau	Paris
France	Institut Curie	Paris
France	Hôpital Jean Bernard	Poitiers
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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Progression-free survival (PFS)	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	12 months
Secondary	Overall-survival (OS)	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	12 months

External Links

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