Spinal Cord Compression
Chief Investigators : Dr. Shifra Ash and Dr Riccardo Haupt.
Sponsor: Associazione Italiana Ematologia-Oncologia Pediatrica (AIEOP), Italy
Funder/Charity: Hayim-Israel Parent Association and Italian Neuroblastoma Foundation
A prospective registry study aiming to describe the natural history of PNTs presenting with SCI and evaluate the combined effect of different risk factors on neurologic and orthopaedic outcomes.
This study aims to collect information about the outcome of patients with neuroblastoma and spinal cord compression.
It is the first prospective registry collecting clinical, pathological, biological, therapeutic and follow-up data on symptomatic and asymptomatic patients with spinal cord involvement.
The primary aim is:
to describe the natural history and treatments given for patients with peripheral neuroblastic tumours presenting with spinal cord involvement, in order, to evaluate the combined effects of risk factors and to develop treatment guidelines.
Secondary aims are:
to correlate the pathologic and biological characteristics with the clinical features, response to therapy and sequelae
to share the diagnostic and therapeutic approaches adopted in the participating centres
to increase the communication regarding patients with a peripheral neuroblastic tumour presenting with spinal cord involvement
to develop common guidelines for the management of children with any peripheral neuroblastic tumour presenting with spinal cord involvement.
There are also two parallel studies:
Neuroradiological review and Scoring by a neuroradiology panel
Data collection study on infant patients with Peripheral Neuroblastic Tumours presenting with Spinal Canal Involvement
The study is recruiting all patients younger than 18 years of age, with the diagnosis of peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with either symptomatic or asymptomatic spinal cord involvement. Patients can be enrolled for study at initial diagnosis or relapse/progression can be enrolled, providing that they have not had previous chemotherapy, except corticosteroids, in the last 6 months
The study opened in June 2014 and is expected to complete recruitment in June 2021, closing it in 2029. In August 2023, it had already recruited 264 patients. It is currently open in 18 countries, which are: Italy, Israel, Ireland, The Netherlands, Poland, Slovakia, Norway, Spain, France, Sweden, Russia, Japan, Germany, Portugal, Belgium, Switzerland, Australia and Austria.
