About this trial
To describe the natural history of peripheral neuroblastic tumour presenting with SCI and evaluate the combined effects of different risk factors on the eventual neurologic and orthopaedic outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of peripheral neuroblastic tumour - peripheral neuroblastic tumour (neuroblastoma, ganglioneuroblastoma, ganglioneuroma) presenting with SCI, symptomatic or asymptomatic, independent of disease extension (stage), and clinical course (first diagnosis or relapse/progression)
No previous chemotherapy, except steroids, in the last 6 months
Age <18 years
Minimal planned follow-up of 5 years
Disqualifiers
Invasion of intervertebral foramina only
Trial population
Patients in the age range 0-18 years diagnosed with peripheral neuroblastic tumour and SCI in the period from May 2014 to April 2017
Trial design
Cohort
Prospective
Treatments tested in this trial
survival and late effects
Other interventionsurvival and late effects
Treatment groups
Trial outcomes
Primary outcomes
prevalence of neurologic consequences
American Spinal Injury Association ASIA impairment scale
prevalence of orthopedic consequences
using Common Terminology Criteria for Adverse Events v. 4.0
prevalence of pain
using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
Secondary outcomes
relapse or second tumour
event free survival
survival
overall survival
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Associazione Italiana Ematologia Oncologia Pediatrica
Lead sponsor
Istituto Giannina Gaslini
Collaborator