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NCT Number: NCT05192980

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

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.

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Key information

Conditions

Neuroblastoma Ganglioneuroblastoma Ganglioneuroma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fakultni nemocnice v Motole, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No Intervention NA

Other

Additional blood sampling (not mandatory)

Other names: Bio-sampling

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gudrun Schleiermacher, MD,PhD

CONTACT

[email protected]

0144324554

Kamel BOURZAH, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: BIOPORTAL

Important dates

Study start
2023
Primary completion
2038
Study completion
2038
First posted
Jan 14, 2022
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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