Observational Registry Study to Evaluate Safety and Effectiveness of Dinutuximab Beta in Children with High-Risk Neuroblastoma

What this Trial Is About

Researchers are observing patients with high-risk neuroblastoma, a common childhood cancer typically diagnosed under age 5, to further evaluate the safety and effects of dinutuximab beta, a monoclonal antibody treatment. This study aims to gather detailed information on survival, pain levels, and the occurrence of side effects such as neurotoxicity, visual problems, capillary leak syndrome, heart events, and allergic reactions. It is a non-interventional, multinational registry designed to follow patients over time. The study collects information from patients being treated with dinutuximab beta either in standard clinical practice or as part of clinical trials where the drug is authorized. Data on treatment dosing, pain management, and side effects are gathered during up to five treatment cycles, each lasting 35 days. Researchers will also monitor long-term safety and patient outcomes through follow-up visits after treatment completion. Participants, who are children aged 1 to 18 years with high-risk neuroblastoma, will have their medical data recorded at baseline, during treatment, and at follow-up visits. This includes assessments of pain, side effects, disease progression, and survival. Data is collected electronically from medical records, and patients will be followed for up to 10 years to provide comprehensive safety and effectiveness information.

A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta