Dinutuximab Beta at the HUS and the Toulouse Oncopole (DNB)

February 16, 2024 updated by: University Hospital, Strasbourg, France

Dinutuximab Beta at the Strasbourg University Hospitals (HUS) and the Toulouse Oncopole: Comparative Analysis of Patient Pathways, Associated Costs and Quality of Life According to Traditional Hospitalization or Hospital at Home (HAD)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Pharmacie - Stérilisation - CHU de Strasbourg - France
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne EL AATMANI, Pharm, PhD
        • Principal Investigator:
          • Emilie BERTHON, PhamD, PhD
        • Principal Investigator:
          • Sophie PERRIAT, PhamD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: The period concerned is from January 1, 1998 to December 31, 2023.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 28, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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