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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05192980
Other study ID # IC 2020-17
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 2, 2023
Est. completion date November 2, 2038

Study information

Verified date April 2024
Source Institut Curie
Contact Gudrun Schleiermacher, MD,PhD
Phone 0144324554
Email gudrun.schleiermacher@curie.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date November 2, 2038
Est. primary completion date November 2, 2038
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention NA
Additional blood sampling (not mandatory)

Locations

Country Name City State
France CHU Amiens Amiens
France Chu Angers Angers
France Hôpital Jean Minjoz Besançon
France Hôpital des enfants Bordeaux
France Chru Brest Brest
France CHU CAEN - Fédération de cancérologie - niveau 21 Caen
France CHU D'Estaing de CLERMONT FERRAND Clermont-Ferrand
France DIJON Hôpital d'enfants Dijon
France Chu Grenoble Grenoble
France Centre Oscar Lambret Lille
France Centre Léon Bérard Lyon
France Hôpital d'Enfants de la Timone Marseille
France Hôpital Arnaud de Villeneuve Montpellier
France Chr Nantes Nantes
France CHU NICE Nice
France Hôpital Armand Trousseau Paris
France Institut Curie Paris
France Hôpital Jean Bernard Poitiers
France Chu Reims Reims
France Chu Hopital Sud Rennes
France Hôpital Charles NICOLLE Rouen
France Hôpital Nord Saint-Étienne
France Hôpital Hautepierre-CHU Strasbourg Strasbourg
France Hôpital des Enfants Toulouse
France Hôpital Clocheville Tours
France CHU NANCY- Hôpital d'Enfants VandÅ“uvre-lès-Nancy
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Primary 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 6 months
Secondary 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 12 months
Secondary 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 12 months
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