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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02559804
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT02559804
Ethics application status
Date submitted
11/09/2015
Date registered
24/09/2015
Date last updated
15/04/2024
Titles & IDs
Public title
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
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Scientific title
Prospective Study Registry of Peripheral Neuroblastic Tumours Presenting With Spinal Canal Involvement (SCI)
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Secondary ID [1]
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NB with SCI
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Universal Trial Number (UTN)
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Trial acronym
NB-SCI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroblastic Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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prevalence of neurologic consequences
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Assessment method [1]
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American Spinal Injury Association ASIA impairment scale
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Timepoint [1]
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for 5 years
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Primary outcome [2]
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prevalence of orthopedic consequences
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Assessment method [2]
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using Common Terminology Criteria for Adverse Events v. 4.0
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Timepoint [2]
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for 5 years
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Primary outcome [3]
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prevalence of pain
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Assessment method [3]
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using Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
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Timepoint [3]
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for 5 years
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Secondary outcome [1]
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relapse or second tumour
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Assessment method [1]
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event free survival
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Timepoint [1]
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5 years
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Secondary outcome [2]
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survival
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Assessment method [2]
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overall survival
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Timepoint [2]
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5 years
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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))
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Minimum age
No limit
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Invasion of intervertebral foramina only
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2029
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Italy
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State/province [1]
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Genova
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Funding & Sponsors
Primary sponsor type
Other
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Name
Associazione Italiana Ematologia Oncologia Pediatrica
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Istituto Giannina Gaslini
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT02559804
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Riccardo Haupt, MD
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Address
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Istituto Giannina Gaslini Genova
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Riccardo Haupt, MD
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Address
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Country
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Phone
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01056363462
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Fax
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0
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/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
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Dr
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Name
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Toby Trahair
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Address
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Kids Cancer Centre Level 1, South Wing Sydney Children's Hospital High Street Randwick, NSW 2031
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Country
149
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Australia
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Phone
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+61 2 9382 2970
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Fax
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+61 2 9382 1789
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Email
149
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[email protected]
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Contact person for public queries
Title
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Mrs
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Name
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Robyn Strong
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Address
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27-31 Wright Street, Clayton VIC 3168
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Country
150
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Australia
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Phone
150
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+613 8572 2684
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Fax
150
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+613 9902 4810
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Email
150
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[email protected]
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Contact person for scientific queries
Title
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Dr
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Name
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Toby Trahair
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Address
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Kids Cancer Centre Level 1, South Wing Sydney Children's Hospital High Street Randwick, NSW 2031
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Country
151
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Australia
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Phone
151
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+61 2 9382 2970
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Fax
151
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+61 2 9382 1789
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Email
151
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[email protected]
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