NeuroblastomaDNBNCT06275334
Dinutuximab Beta at the HUS and the Toulouse Oncopole
An observational study of Neuroblastoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Neuroblastoma
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to 28 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pharmacie - Stérilisation - CHU de Strasbourg - France
Strasbourg, 67091
Anne EL AATMANI, Pharm, PhD, 33 3 88 12 78 06, Anne.ELAATMANI@chru-strasbourg.fr
Emilie BERTHON, Pharm, PhD, 33 3 88 12 78 06, emilieberthon@orange.fr
About this study
Official title: 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.
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, Dinutuximab Beta, DNB
- Medical subject headings
- Neuroblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The period concerned is from January 1, 1998 to December 31, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start28 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completion28 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275334
- Sponsor's protocol ID
- 9133
- Acronym
- DNB
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06275334
- Acronym / sponsor ID
- DNB / 9133
- Conditions
- Neuroblastoma
- Keywords
- Neuroblastoma, Dinutuximab Beta, DNB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- 28 Nov 2024 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Related trials for Neuroblastoma
RecruitingPhase 1/2
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne EL AATMANI, Pharm, PhD (33 3 88 12 78 06, Anne.ELAATMANI@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.