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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Hopital 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
        • Hôpital 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
        • Hôpital Charles Nicolle
        • Principal Investigator:
          • Aude MARIE CARDINE, MD
      • Saint-Étienne, France, 42055
        • Not yet recruiting
        • Hôpital Nord
        • Principal Investigator:
          • Claire BERGER, MD
      • Strasbourg, France, 67098
        • Recruiting
        • Hôpital Hautepierre-CHU Strasbourg
        • Principal Investigator:
          • Sarah JANNIER, MD
      • Toulouse, France, 70034
        • Recruiting
        • Hopital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2038

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2038

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Neuroblastoma

Clinical Trials on No Intervention NA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings