NeuroblastomaBIOPORTALNCT05192980
SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
A study of Neuroblastoma and Ganglioneuroblastoma, run by Institut Curie at 38 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 38 sitesin 4 countries
- Study dates
- 2 Nov 2023to 2 Nov 2038
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
38 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Kamel BOURZAH, MD contact
38 sites in 4 countries
France27 sites, 27 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Antoine GOURMEL, MD
- Recruiting
Chu Angers
Angers, 49033
Stéphanie PROUST, MD
- Recruiting
Hôpital Jean Minjoz
Besançon, 25030
Veronique LAITHIER, MD
- Recruiting
Hôpital des enfants
Bordeaux, 33076
Julie TANDONNET, MD
- Recruiting
Chru Brest
Brest, 29609
Liana CARAUSU, MD
- Recruiting
CHU CAEN - Fédération de cancérologie - niveau 21
Caen, 14033
Damien BODET, MD
- Recruiting
CHU D'Estaing de CLERMONT FERRAND
Clermont-Ferrand, 63003
Justyna KANOLD, MD
- Recruiting
DIJON Hôpital d'enfants
Dijon, 21079
Claire BRIANDET, MD
- Recruiting
Chu Grenoble
Grenoble, 38045
Cécile PERRET, MD
- Recruiting
Centre Oscar Lambret
Lille, 59020
Anne-Sophie DEFACHELLES, MD
- Recruiting
Centre Léon Bérard
Lyon, 69373
Benoît DUMONT, MD
- Recruiting
Hôpital d'Enfants de la Timone
Marseille, 13385
Carole COZE, MD
- Recruiting
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Tasnime AKBARALY, MD
- Recruiting
Chr Nantes
Nantes, 44093
Estelle THEBAUD, MD
- Recruiting
CHU NICE
Nice, 06202
Joy BENADIBA, MD
- Recruiting
Institut Curie
Paris, 750248
Gudrun SCHLEIERMACHER, MD, 0144324551, gudrun.schleiermacher@curie.fr
Gudrun SCHLEIERMACHER, MD
- Recruiting
Hôpital Armand Trousseau
Paris, 75571
Arnaud PETIT, MD
- Not yet recruiting
Hôpital Jean Bernard
Poitiers, 86021
Chrystelle DUPRAZ, MD
- Recruiting
Chu Reims
Reims, 51092
Claire PLUCHART, MD
- Recruiting
Chu Hopital Sud
Rennes, 35056
Sophie TAQUE, MD
- Recruiting
Hôpital Charles NICOLLE
Rouen, 76031
Aude MARIE CARDINE, MD
- Not yet recruiting
Hôpital Nord
Saint-Etienne, 42055
Claire BERGER, MD
- Recruiting
Hôpital Hautepierre-CHU Strasbourg
Strasbourg, 67098
Sarah JANNIER, MD
- Recruiting
Hôpital des Enfants
Toulouse, 70034
Marion GAMBART, MD
- Not yet recruiting
Hôpital Clocheville
Tours, 37044
Julien LEJEUNE, MD
- Recruiting
CHU NANCY- Hôpital d'Enfants
Vandœuvre-lès-Nancy, 54500
Ludovic MANSUY, MD
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Claudia PASQUALINI, MD
Switzerland9 sites, 9 recruiting
- Recruiting
Kantonsspital Aarau AG
Aarau, 5001
Andreas Klein-Franke, MD, andreas.klein-franke@ksa.ch
Andreas Klein-Franke, MD
- Recruiting
Universitäts-Kinderspital beider Basel UKBB
Basel, 4056
Nicolas von der Weid, MD, nicolas.vonderweid@ukbb.ch
Nicolas von der Weid, MD
- Recruiting
Ospedale San Giovanni
Bellinzona, 6500
Mattia Rizzi, MD, mattia.rizzi@eoc.ch
Mattia Rizzi, MD
- Recruiting
Inselspital Bern
Bern, 3010
Miriam Diepold, MD, miriam.diepold@insel.ch
Miriam Diepold, MD
- Recruiting
HUG Hôpitaux Universitaires Genève
Geneva, 1205
Fabienne Gumy-Pause, MD
Fabienne Gumy-Pause, MD
- Recruiting
CHUV, Centre hospitalier universitaire vaudois
Lausanne, 1011
Raffaele Renella, MD, raffaele.renella@chuv.ch
Raffaele Renella, MD
- Recruiting
Kinderspital Zentralschweiz, Luzern
Lucerne, 6000
Freimut H. Schilling, MD, freimut.schilling@luks.ch
Freimut H. Schilling, MD
- Recruiting
Ostschweizer Kinderspital
Sankt Gallen, 9006
Cornelia Vetter, MD, cornelia.vetter@kispisg.ch
Cornelia Vetter, MD
- Recruiting
Universitäts-Kinderspital Zürich
Zurich, 8091
Sabine Kroiss Benninger, MD, sabine.kroiss@kispi.uzh.ch
Sabine Kroiss Benninger, MD
Czechia1 site, 1 recruiting
- Recruiting
Fakultni nemocnice v Motole
Prague, 150 06
Vícha Aleš, MD, ales.vicha@fnmotol.cz
Vícha Aleš, MD
Norway1 site, 1 recruiting
- Recruiting
Oslo Universitetssykehus
Oslo, 0424
Kirsten Brunsvig Jarvis, MD, kirjar@ous-hf.no
Kirsten Brunsvig Jarvis, MD
About this study
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.
- Conditions
- Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
- Being tested
- No Intervention NA
- Medical subject headings
- Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention NAOther
Also called Bio-sampling
Additional blood sampling (not mandatory)
| Study group | Role | What they receive |
|---|---|---|
| Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma) | Other | Not described Receives: Other: No Intervention NA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (2)
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
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start2 Nov 2023
- Primary completion2 Nov 2038 (estimated)
- Study completion2 Nov 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192980
- Sponsor's protocol ID
- IC 2020-17
- Acronym
- BIOPORTAL
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2021
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
- ClinicalTrials.gov ID
- NCT05192980
- Acronym / sponsor ID
- BIOPORTAL / IC 2020-17
- Conditions
- Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 2 Nov 2038 (estimated)
- Study completion
- 2 Nov 2038 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma) | Other | Other: No Intervention NA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- R-1. (Adult) Patients with olfactory neuroblastoma R-2. Central nervous system (CNS) neuroblastoma (as per the WHO classification)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention NAAlso: Bio-samplingAdditional blood sampling (not mandatory) | Other | Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma) |
Primary outcome
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
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
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 12 months
Overall-survival (OS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kamel BOURZAH, MD contact
38 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neuroblastoma and Ganglioneuroblastoma, run by Institut Curie at 38 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in France, Switzerland, Czechia, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gudrun Schleiermacher, MD,PhD (0144324554, gudrun.schleiermacher@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients having their clinical data registered (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.