PASS Registry of patient’s with high-risk neuroblastoma
Research type
Research Study
Full title
A Post-Authorisation Safety Study Patient Registry of patients with high-risk neuroblastoma being treated with the monoclonal antibody dinutuximab beta
IRAS ID
263084
Contact name
Juliet Gray
Contact email
Sponsor organisation
EUSA Pharma (UK) Ltd
Duration of Study in the UK
12 years, 1 months, 15 days
Research summary
This study is a multi-national,observational, prospective registry of patients with high-risk neuroblastoma treated with dinutuximab beta. The study is non-interventional. All investigations and treatment decisions are made according to normal clinical practice and are not mandated by the protocol.\n\nData collection will occur at baseline, during treatment and during the 10 year follow-up period.During the treatment phase, data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs. The study will have a 10 year follow-up period and the data will be collected from the subject approximately 14 times during this 10 year period. The doctor will collect information from the subject four times in the first year (approximately every three months in Year 1), two times in the second year (six monthly in Year 2) and once a year after that up until Year 10. \n \nCountries participating in this study may include (but is not restricted to) Austria, France, Spain, Italy, Germany, Poland and the United, Kingdom. \n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0298
Date of REC Opinion
9 Dec 2019
REC opinion
Further Information Favourable Opinion