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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
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neuroblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 13, 2021
    Last Updated
    December 31, 2021
    Sponsor
    Institut Curie
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    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

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

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