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

April 16, 2024 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

  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU Amiens
        • Principal Investigator:
          • Antoine Gourmel, MD
      • Angers, France, 49033
        • Not yet recruiting
        • CHU Angers
        • Principal Investigator:
          • Stéphanie PROUST, MD
      • Besançon, France, 25030
        • Not yet recruiting
        • Hopital Jean Minjoz
        • Principal Investigator:
          • Véronique Laithier, MD
      • Bordeaux, France, 33076
        • Not yet recruiting
        • Hopital des Enfants
        • Principal Investigator:
          • Julie TANDONNET, MD
      • Brest, France, 29609
        • Not yet recruiting
        • CHRU Brest
        • Principal Investigator:
          • Liana CARAUSU, MD
      • Caen, France, 14033
        • Not yet recruiting
        • CHU CAEN - Fédération de cancérologie - niveau 21
        • Principal Investigator:
          • Damien BODET, MD
      • Clermont-Ferrand, France, 63003
        • Not yet recruiting
        • CHU D'Estaing de CLERMONT FERRAND
        • Principal Investigator:
          • Justyna Kanold, MD
      • Dijon, France, 21079
        • Not yet recruiting
        • DIJON Hôpital d'enfants
        • Principal Investigator:
          • Claire Briandet, MD
      • Grenoble, France, 38045
        • Not yet recruiting
        • CHU Grenoble
        • Principal Investigator:
          • Cécile PERRET, MD
      • Lille, France, 59020
        • Not yet recruiting
        • Centre Oscar Lambret
        • Principal Investigator:
          • Anne-Sophie DEFACHELLES, MD
      • Lyon, France, 69373
        • Not yet recruiting
        • Centre Léon Bérard
        • Principal Investigator:
          • Benoît DUMONT, MD
      • Marseille, France, 13385
        • Not yet recruiting
        • Hopital d'Enfants de la Timone
        • Principal Investigator:
          • Carole COZE, MD
      • Montpellier, France, 34295
        • Not yet recruiting
        • Hopital Arnaud de Villeneuve
        • Principal Investigator:
          • Tasnime AKBARALY, MD
      • Nantes, France, 44093
        • Not yet recruiting
        • Chr Nantes
        • Principal Investigator:
          • Estelle THEBAUD, MD
      • Nice, France, 06202
        • Not yet recruiting
        • CHU Nice
        • Principal Investigator:
          • Joy BENADIBA, MD
      • Paris, France, 750248
        • Recruiting
        • Institut Curie
        • Contact:
        • Principal Investigator:
          • Gudrun SCHLEIERMACHER, MD
      • Paris, France, 75571
        • Not yet recruiting
        • Hôpital Armand Trousseau
        • Principal Investigator:
          • Arnaud PETIT, MD
      • Poitiers, France, 86021
        • Not yet recruiting
        • Hopital jean Bernard
        • Principal Investigator:
          • Chrystelle DUPRAZ, MD
      • Reims, France, 51092
        • Not yet recruiting
        • CHU Reims
        • Principal Investigator:
          • Claire Pluchart, MD
      • Rennes, France, 35056
        • Not yet recruiting
        • CHU Hôpital Sud
        • Principal Investigator:
          • Sophie TAQUE, MD
      • Rouen, France, 76031
        • Not yet 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
        • Not yet recruiting
        • Hôpital Hautepierre-CHU Strasbourg
        • Principal Investigator:
          • Sarah JANNIER, MD
      • Toulouse, France, 70034
        • Not yet 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
        • Not yet recruiting
        • CHU NANCY- Hôpital d'Enfants
        • Principal Investigator:
          • Ludovic MANSUY, MD
      • Villejuif, France, 94800
        • Not yet recruiting
        • Institut Gustave Roussy
        • Principal Investigator:
          • Claudia PASQUALINI, 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)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

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

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

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe