NCT06275334

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 1, 2024

Last Update Submit

February 16, 2024

Conditions

Keywords

NeuroblastomaDinutuximab BetaDNB

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age2 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pharmacie - Stérilisation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Anne EL AATMANI, Pharm, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 23, 2024

Study Start

November 28, 2023

Primary Completion

November 1, 2024

Study Completion

November 28, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

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