Clinical trial NCT05192980: SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
Official title: SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroblastoma
Ganglioneuroblastoma
Ganglioneuroma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Rate of patients having their clinical data registered
timeFrame: 6 months
measure: Rate of patients for whom information on biological samples/material is collected
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: Overall-survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: Chu Angers
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Hôpital des enfants
city: Brest
country: France
facility: Chru Brest
city: Caen
country: France
facility: CHU CAEN - Fédération de cancérologie - niveau 21
city: Clermont-Ferrand
country: France
facility: CHU D'Estaing de CLERMONT FERRAND
city: Dijon
country: France
facility: DIJON Hôpital d'enfants
city: Grenoble
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Hôpital d'Enfants de la Timone
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nantes
country: France
facility: Chr Nantes
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Poitiers
country: France
facility: Hôpital Jean Bernard
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu Hopital Sud
city: Rouen
country: France
facility: Hôpital Charles NICOLLE
city: Saint-Étienne
country: France
facility: Hôpital Nord
city: Strasbourg
country: France
facility: Hôpital Hautepierre-CHU Strasbourg
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Tours
country: France
facility: Hôpital Clocheville
city: Vandœuvre-lès-Nancy
country: France
facility: CHU NANCY- Hôpital d'Enfants
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: