Actively Recruiting
A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Led by RECORDATI GROUP · Updated on 2024-02-07
125
Participants Needed
13
Research Sites
10 weeks
Total Duration
On this page
Sponsors
R
RECORDATI GROUP
Lead Sponsor
U
United BioSource, LLC
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with high-risk neuroblastoma and starting treatment with commercially available dinutuximab beta
- Patients diagnosed with high-risk neuroblastoma and starting treatment with dinutuximab beta in a clinical trial where the drug is provided according to country/regional marketing authorization
- Appropriate consent or assent obtained for participation and willingness to be followed for up to 10 years
You will not qualify if you...
- Patients starting dinutuximab beta in a clinical trial where the product is provided outside of country/regional marketing authorization
- Lack of appropriate consent or assent for participation or unwillingness for follow-up up to 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 175 days (5 cycles of 35 days each)
Participants starting treatment with dinutuximab beta are observed to collect data on dosing, pain severity, analgesic use, and occurrence of side effects including neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events, and hypersensitivity reactions during treatment.
Visits scheduled according to standard clinical practice during the 5 treatment cycles
Duration - Up to 10 years
Participants are followed up after treatment ends for up to 10 years to assess long-term safety, progression of disease, and survival outcomes.
Follow-up visits per routine clinical practice
Trial Site Locations
Total: 13 locations
1
St. Anna Kinderkrebsforschung
Vienna, State of Vienna, Austria, 1090
Active, Not Recruiting
2
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
3
Hôpital de la Timone, Hôpital des Enfants
Marseille, France, 13385
Actively Recruiting
4
Institut Curie
Paris, France, 75005
Active, Not Recruiting
5
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
6
Charité Berlin
Berlin, Germany, 13353
Actively Recruiting
7
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
Actively Recruiting
8
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
9
Uniwersytecki Szpital Dziecięcy
Krakow, Poland, 30-663
Actively Recruiting
10
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell
Valencia, Spain, 46026
Actively Recruiting
11
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
12
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Active, Not Recruiting
13
University Hospital Southampton
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
J
Jose-Luis Garcia
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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