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

ConditionsNeuroblastomaGanglioneuroblastomaGanglioneuroma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstitut Curie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • No Intervention NA

    Other intervention

    Additional blood sampling (not mandatory)

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months
2

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Curie

Lead sponsor

Source ClinicalTrials.gov
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