Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAssociazione Italiana Ematologia Oncologia Pediatrica

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • survival and late effects

    Other intervention

    survival and late effects

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: patients NB with SCI1 intervention

Trial outcomes

Primary outcomes

1

prevalence of neurologic consequences

American Spinal Injury Association ASIA impairment scale

Time frame
for 5 years
2

prevalence of orthopedic consequences

using Common Terminology Criteria for Adverse Events v. 4.0

Time frame
for 5 years
3

prevalence of pain

using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)

Time frame
for 5 years

Secondary outcomes

1

relapse or second tumour

event free survival

Time frame
5 years
2

survival

overall survival

Time frame
5 years

Other outcomes

Sponsors and contacts

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