SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours (BIOPORTAL)
Primary Purpose
Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No Intervention NA
Sponsored by
About this trial
This is an interventional other trial for Neuroblastoma
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05192980
Brief Title
SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
Acronym
BIOPORTAL
Official Title
SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2037 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Ganglioneuroblastoma, Ganglioneuroma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peripheral neuroblastic tumors (ganglioneuroma, ganglioneuroblastoma and neuroblastoma)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
No Intervention NA
Other Intervention Name(s)
Bio-sampling
Intervention Description
Additional blood sampling (not mandatory)
Primary Outcome Measure Information:
Title
Rate of patients having their clinical data registered
Description
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
Title
Rate of patients for whom information on biological samples/material is collected
Description
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 Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Title
Overall-survival (OS)
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gudrun Schleiermacher, MD,PhD
Phone
0625154331
Email
gudrun.schleiermacher@curie.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Caterina Sansone, PharmD
Email
caterina.sansone@curie.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.siopen.net/
Description
Related Info
Learn more about this trial
SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours
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