Actively Recruiting
A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Led by RECORDATI GROUP · Updated on 2024-02-07
125
Participants Needed
13
Research Sites
663 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
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.
CONDITIONS
Official 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 it is provided according to country/regional marketing authorisation
- Appropriate consent/assent obtained for participation with willingness for up to 10 years follow-up
You will not qualify if you...
- Patients starting dinutuximab beta in a clinical trial where the product is provided outside of country/regional marketing authorisation
- Consent/assent not obtained or unwillingness for follow-up for up to 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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