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SIOPEN BIOPORTAL, an International Registry Linked to a Virtual Biobank for Patients with Peripheral Neuroblastic Tumours

I

Institut Curie

Status

Enrolling

Conditions

Neuroblastoma
Ganglioneuroma
Ganglioneuroblastoma

Treatments

Other: No Intervention NA

Study type

Interventional

Funder types

Other

Identifiers

NCT05192980
IC 2020-17

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)
Other group
Treatment:
Other: No Intervention NA

Trial contacts and locations

27

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Central trial contact

Gudrun Schleiermacher, MD,PhD; Kamel BOURZAH, MD

Data sourced from clinicaltrials.gov

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