Dinutuximab Beta at the HUS and the Toulouse Oncopole | NCT06275334

Studies
Dinutuximab Beta at the HUS and the Toulouse Oncopole

NCT06275334

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Feb 23, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Neuroblastoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2023Actual

Primary Completion Date

Nov 2024Estimated

Completion Date

Nov 28, 2024Estimated

First Submitted Date

Feb 1, 2024

First Submission Date that Met QC Criteria

Feb 16, 2024

First Posted Date

Feb 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2024

Last Update Posted Date

Feb 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse.	This study is retrospective and consists of comparing two methods of treating neuroblastoma in two health establishments and covers the period from January 1, 1998 to December 31, 2023.	The period concerned is from January 1, 1998 to December 31, 2023.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged 2 years to 25 years
Male or female gender
Subjects suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.
Subject (and/or holders of parental authority) not opposing, after information, the reuse of the child's data for the purposes of this research and agreeing to respond to the quality of life survey.

Exclusion Criteria:

Patient or parents of the minor having expressed their opposition to participating in the study.
specific clinical forms of the disease,
interfering treatments and associated diseases.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Subjects aged 2 years to 25 years suffering from neuroblastoma and treated at the HUS or at the Oncopole center in Toulouse during the period from January 1, 1998 to December 31, 2023.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne EL AATMANI, Pharm, PhD	Contact	33 3 88 12 78 06		Anne.ELAATMANI@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Pharmacie - Stérilisation - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D009447	Neuroblastoma

Ancestor Terms

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided