NCT04253015Active, not recruiting
A Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 125 (actual)
- First submitted
- 27 Jan 2020
- Start date
- 30 Sept 2019
- Primary completion date
- 30 Jun 2036
- Lead sponsor
- RECORDATI GROUP
- Diseases
- Neuroblastoma, Childhood cancers
- NCT number
- NCT04253015
What you commit to
- Study type: Observational
- Participants enrolled: 125
- From 30 Sept 2019 to the primary completion date, 30 Jun 2036
- 13 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient will not be eligible for inclusion if the following criterion applies:
- Patients commencing dinutuximab beta within a clinical trial where the product is being provided outside of the country/regional marketing authorisation OR
- Appropriate consent/assent has not been obtained for participation in the registry or patient/legal representative is not willing for the patient be followed up for up to 10 years.
Who the study is looking for
- Patients meeting the following criteria will be considered for inclusion into the registry:
- Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta OR
- Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where dinutuximab beta is provided according to the country/regional marketing authorisation AND
- Appropriate consent/assent has been obtained for participation in the registry with a willingness to be followed up for up to 10 years.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anna Kinderkrebsforschung Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Charité Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsmedizin Greifswald Coordinator of this site? Confirm its status | Greifswald | Germany | Unknown status |
| Vall d'Hebron University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital de la Timone, Hôpital des Enfants Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Birmingham Children's Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Uniwersytecki Szpital Dziecięcy Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.