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

July 17, 2025 updated by: Institut Curie

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole
        • Contact:
        • Principal Investigator:
          • Vícha Aleš, MD
  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Principal Investigator:
          • Antoine GOURMEL, MD
      • Angers, France, 49033
        • Recruiting
        • CHU Angers
        • Principal Investigator:
          • Stéphanie PROUST, MD
      • Besançon, France, 25030
        • Recruiting
        • Hôpital Jean Minjoz
        • Principal Investigator:
          • Véronique LAITHIER, MD
      • Bordeaux, France, 33076
        • Recruiting
        • Hôpital des Enfants
        • Principal Investigator:
          • Julie TANDONNET, MD
      • Brest, France, 29609
        • Recruiting
        • CHRU Brest
        • Principal Investigator:
          • Liana CARAUSU, MD
      • Caen, France, 14033
        • Recruiting
        • CHU CAEN - Fédération de cancérologie - niveau 21
        • Principal Investigator:
          • Damien BODET, MD
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU D'Estaing de CLERMONT FERRAND
        • Principal Investigator:
          • Justyna KANOLD, MD
      • Dijon, France, 21079
        • Recruiting
        • DIJON Hôpital d'enfants
        • Principal Investigator:
          • Claire BRIANDET, MD
      • Grenoble, France, 38045
        • Recruiting
        • CHU Grenoble
        • Principal Investigator:
          • Cécile PERRET, MD
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Anne-Sophie DEFACHELLES, MD
      • Lyon, France, 69373
        • Recruiting
        • Centre Leon Berard
        • Principal Investigator:
          • Benoit DUMONT, MD
      • Marseille, France, 13385
        • Recruiting
        • Hôpital d'Enfants de la Timone
        • Principal Investigator:
          • Carole COZE, MD
      • Montpellier, France, 34295
        • Recruiting
        • Hopital Arnaud de Villeneuve
        • Principal Investigator:
          • Tasnime AKBARALY, MD
      • Nantes, France, 44093
        • Recruiting
        • Chr Nantes
        • Principal Investigator:
          • Estelle THEBAUD, MD
      • Nice, France, 06202
        • Recruiting
        • CHU Nice
        • Principal Investigator:
          • Joy BENADIBA, MD
      • Paris, France, 75571
        • Recruiting
        • Hôpital Armand Trousseau
        • Principal Investigator:
          • Arnaud PETIT, MD
      • Paris, France, 750248
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Gudrun SCHLEIERMACHER, MD
      • Poitiers, France, 86021
        • Not yet recruiting
        • Hopital Jean Bernard
        • Principal Investigator:
          • Chrystelle DUPRAZ, MD
      • Reims, France, 51092
        • Recruiting
        • CHU Reims
        • Principal Investigator:
          • Claire PLUCHART, MD
      • Rennes, France, 35056
        • Recruiting
        • CHU Hopital Sud
        • Principal Investigator:
          • Sophie TAQUE, MD
      • Rouen, France, 76031
        • Recruiting
        • Hopital Charles Nicolle
        • Principal Investigator:
          • Aude MARIE CARDINE, MD
      • Saint-Étienne, France, 42055
        • Not yet recruiting
        • Hopital Nord
        • Principal Investigator:
          • Claire BERGER, MD
      • Strasbourg, France, 67098
        • Recruiting
        • Hôpital Hautepierre-CHU Strasbourg
        • Principal Investigator:
          • Sarah JANNIER, MD
      • Toulouse, France, 70034
        • Recruiting
        • Hôpital des Enfants
        • Principal Investigator:
          • Marion GAMBART, MD
      • Tours, France, 37044
        • Not yet recruiting
        • Hôpital Clocheville
        • Principal Investigator:
          • Julien LEJEUNE, MD
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • CHU NANCY- Hôpital d'Enfants
        • Principal Investigator:
          • Ludovic MANSUY, MD
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Claudia PASQUALINI, MD
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Oslo Universitetssykehus
        • Contact:
        • Principal Investigator:
          • Kirsten Brunsvig Jarvis, MD
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau AG
        • Contact:
        • Principal Investigator:
          • Andreas Klein-Franke, MD
      • Basel, Switzerland, 4056
        • Recruiting
        • Universitäts-Kinderspital beider Basel UKBB
        • Principal Investigator:
          • Nicolas von der Weid, MD
        • Contact:
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Ospedale San Giovanni
        • Contact:
        • Principal Investigator:
          • Mattia Rizzi, MD
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Contact:
        • Principal Investigator:
          • Miriam Diepold, MD
      • Genève, Switzerland, 1205
        • Recruiting
        • HUG Hôpitaux Universitaires Genève
        • Contact:
          • Fabienne Gumy-Pause, MD
        • Principal Investigator:
          • Fabienne Gumy-Pause, MD
      • Lausanne, Switzerland, 1011
        • Recruiting
        • CHUV, Centre hospitalier universitaire vaudois
        • Contact:
        • Principal Investigator:
          • Raffaele Renella, MD
      • Luzern, Switzerland, 6000
        • Recruiting
        • Kinderspital Zentralschweiz, Luzern
        • Contact:
        • Principal Investigator:
          • Freimut H. Schilling, MD
      • St. Gallen, Switzerland, 9006
        • Recruiting
        • Ostschweizer Kinderspital
        • Contact:
        • Principal Investigator:
          • Cornelia Vetter, MD
      • Zürich, Switzerland, 8091
        • Recruiting
        • Universitäts-Kinderspital Zürich
        • Contact:
        • Principal Investigator:
          • Sabine Kroiss Benninger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)
Other: No Intervention NA
Additional blood sampling (not mandatory)
Other Names:
  • Bio-sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients having their clinical data registered
Time Frame: 6 months
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
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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
12 months
Overall-survival (OS)
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

November 2, 2038

Study Completion (Estimated)

November 2, 2038

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2020-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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