A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Recruiting now
Conditions studied: Neuroblastoma
In brief
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.
Key facts
- Study ID
- NCT04253015
- Run by
- RECORDATI GROUP
- People needed
- 125
- Starts
- 2019-09-30
- Expected to finish
- 2032-06-15
- Last updated by the study team
- 2024-02-07
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University Hospital Southampton — Southampton, United Kingdom (enrolling)
- Centre Oscar Lambret — Lille, France (enrolling)
- Hôpital de la Timone, Hôpital des Enfants — Marseille, France (enrolling)
- Uniwersytecki Szpital Dziecięcy — Krakow, Poland (enrolling)
- Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell — Valencia, Spain (enrolling)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Newcastle, United Kingdom (enrolling)
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Charité Berlin — Berlin, Germany (enrolling)
- Universitätsmedizin Greifswald — Greifswald, Germany (enrolling)
- IRCCS Istituto Giannina Gaslini — Genova, Italy (enrolling)
- Institut Curie — Paris, France
- St. Anna Kinderkrebsforschung — Vienna, State of Vienna, Austria
- Birmingham Children's Hospital — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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