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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02559804


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT02559804
Ethics application status
Date submitted
1/07/2016
Date registered
23/09/2015
Date last updated
25/01/2017

Titles & IDs
Public title
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
Scientific title
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
Secondary ID [1] 0 0
NB with SCI
Universal Trial Number (UTN)
Trial acronym
NB-SCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroblastic Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - survival and late effects

patients NB with SCI - Survival and late effects. 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).


Other interventions: survival and late effects
survival and late effects

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
prevalence of neurologic consequences - American Spinal Injury Association ASIA impairment scale
Timepoint [1] 0 0
for 5 years
Primary outcome [2] 0 0
prevalence of orthopedic consequences - using Common Terminology Criteria for Adverse Events v. 4.0
Timepoint [2] 0 0
for 5 years
Primary outcome [3] 0 0
prevalence of pain - using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
Timepoint [3] 0 0
for 5 years
Secondary outcome [1] 0 0
relapse or second tumour - event free survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
survival - overall survival
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
- 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

- Parent/patient written informed consent (Appendix 1(A,B,C))
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Invasion of intervertebral foramina only

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Genova

Funding & Sponsors
Primary sponsor type
Other
Name
Associazione Italiana Ematologia Oncologia Pediatrica
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Istituto Giannina Gaslini
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/show/NCT02559804
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Riccardo Haupt, MD
Address 0 0
Istituto Giannina Gaslini Genova
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Riccardo Haupt, MD
Address 0 0
Country 0 0
Phone 0 0
01056363462
Fax 0 0
Email 0 0
riccardohaupt@ospedale-gaslini.ge.it
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02559804

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,TAS,WA,VIC
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Secondary sponsor category [1] 30
Other Collaborative groups
Name [1] 30
ANZCHOG
Address [1] 30
27-31 Wright Street, Clayton VIC 3168
Country [1] 30
Australia
Ethics approval
Ethics application status
 
Public notes
Monash Children's Hospital
Perth Children's Hospital
Sydney Children's Hospital
Royal Hobart Hospital

Contacts
Principal investigator
Title 149 0
Dr
Name 149 0
Toby Trahair
Address 149 0
Kids Cancer Centre Level 1, South Wing Sydney Children's Hospital High Street Randwick, NSW 2031
Country 149 0
Australia
Phone 149 0
+61 2 9382 2970
Fax 149 0
+61 2 9382 1789
Email 149 0
Toby.Trahair@health.nsw.gov.au
Contact person for public queries
Title 150 0
Mrs
Name 150 0
Robyn Strong
Address 150 0
27-31 Wright Street, Clayton VIC 3168
Country 150 0
Australia
Phone 150 0
+613 8572 2684
Fax 150 0
+613 9902 4810
Email 150 0
Robyn.Strong@hudson.org.au
Contact person for scientific queries
Title 151 0
Dr
Name 151 0
Toby Trahair
Address 151 0
Kids Cancer Centre Level 1, South Wing Sydney Children's Hospital High Street Randwick, NSW 2031
Country 151 0
Australia
Phone 151 0
+61 2 9382 2970
Fax 151 0
+61 2 9382 1789
Email 151 0
Toby.Trahair@health.nsw.gov.au