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Trial registered on ANZCTR


Trial ID
ACTRN12618000006246
Ethics application status
Approved
Date submitted
27/11/2017
Date registered
10/01/2018
Date last updated
10/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Access to Innovative Molecular Diagnostic PROfiling for Paediatric Brain Tumours
Scientific title
Application of innovative molecular profiling techniques to improve diagnosis of paediatric central nervous system tumours and develop an accredited Australasian molecular profiling service.
Secondary ID [1] 293459 0
ACCT009
Universal Trial Number (UTN)
Trial acronym
AIM-BRAIN PROject
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Nervous System Tumours 305637 0
Condition category
Condition code
Cancer 304859 304859 0 0
Brain
Cancer 304860 304860 0 0
Children's - Brain
Cancer 304861 304861 0 0
Children's - Other
Cancer 304862 304862 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate a new diagnostic process for patients under 21 years old with Brain or Spinal Cord tumours, in Australia and New Zealand.

All participants will have blood and tumour samples sent to Monash Health, Clayton, Victoria, where molecular testing will occur. Tumour sampling will be taken during routine diagnostic procedures or time of surgical resection. Blood sampling will be taken at any time following consent. Molecular testing will include, (1) Methylation array analysis, (2) Multiplex Ligation-dependent Probe Amplification (MLPA) analysis, and (3) Neuro-oncology specific gene panel sequencing analysis.

Data generated by the methylation arrays will be compared with a classification algorithm produced by the German Cancer Research Centre (DKFZ) to generate a molecular classification of the tumour.

Concurrently, participants will have standard diagnostic radiology and pathology diagnostic testing at their centres. If the molecular classification matches the diagnosis achieved at the local centre, a report will be sent to the study sponsor (ANZCHOG) and the local treating oncologist. If the results are discrepant, these cases will be subject to central pathology analysis with Australia and an expert Tumour Board will review all the results and reach a consensus diagnosis. A report describing the consensus diagnosis will be sent to the local treating oncologist.

Any changes in treatment approaches based on the AIM-BRAIN Project molecular classification will be recorded.
Intervention code [1] 299700 0
Diagnosis / Prognosis
Comparator / control treatment
Control: Routine diagnosis using radiology and histopathology techniques
Control group
Active

Outcomes
Primary outcome [1] 304060 0
Proportion of cases where the consensus diagnosis determined following DNA methylation profiling and gene panel analysis differs from the diagnosis based on routine imaging and histopathology.
Timepoint [1] 304060 0
6 months post diagnostic testing
Secondary outcome [1] 340816 0
Proportion of patients receiving altered therapy because of this service. Evaluated by a study-specific survey with the Site Principal Investigators.
Timepoint [1] 340816 0
6 months post diagnostic testing
Secondary outcome [2] 341429 0
Overall and progression-free survival per classification group
Timepoint [2] 341429 0
5 and 10 years post diagnosis

Eligibility
Key inclusion criteria
1. Suspected or confirmed primary brain or spinal cord tumour
2. Adequate samples must be provided to the testing centre to allow completion of the molecular profiling studies
3. Age < 21 years
4. Written informed consent
Minimum age
No limit
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 9447 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 9448 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 18162 0
3168 - Clayton
Recruitment postcode(s) [2] 18163 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 298083 0
Charities/Societies/Foundations
Name [1] 298083 0
The Robert Connor Dawes Foundation
Address [1] 298083 0
39 Royal Ave
Sandringham, 3191
Vic, Australia
Country [1] 298083 0
Australia
Funding source category [2] 298086 0
Government body
Name [2] 298086 0
Australian Federal Government through Cancer Australia.
Address [2] 298086 0
Street address: Level 14, 300 Elizabeth Street, Surry Hills NSW 2010

Postal address: Locked Bag 3, STRAWBERRY HILLS NSW 2012
Country [2] 298086 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG)
Address
Hudson Institute
Level 6, TRF Building,
27 - 31Wright Street,
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 297162 0
None
Name [1] 297162 0
Address [1] 297162 0
Country [1] 297162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299105 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 299105 0
The Royal Children’s Hospital
50 Flemington Road,
Parkville, 3052, VIC
Ethics committee country [1] 299105 0
Australia
Date submitted for ethics approval [1] 299105 0
14/09/2017
Approval date [1] 299105 0
20/10/2017
Ethics approval number [1] 299105 0
37258A

Summary
Brief summary
The purpose of this study is to establish and validate new laboratory techniques required for accurately classifying newly diagnosed central nervous system (CNS) tumours (including brain and spinal cord tumours) in children.

Who is it for?
You may be eligible to join this study if you are aged 0 - 21 years old and have been diagnosed with a CNS cancer and undergone surgical resection.

Study details
All participants will have blood and tumour samples sent to Monash Health in Clayton, Victoria, where molecular profiling will occur. Concurrently, participants will have standard diagnostic radiology and pathology diagnostic testing at their centres.
If the molecular diagnosis matches diagnosis achieved at the local centre, a report will be sent to the study sponsor (ANZCHOG) and the local treating oncologist. If the results are discrepant, these cases will be subject to central pathology analysis and an expert Tumour Board will review all the results and reach a consensus diagnosis.

Participant health records will be assessed yearly to record treatment approaches and responses for up to 10 years.

This study will provide valuable data for personalised treatment decisions to optimise survival outcomes and minimise long-term complications
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79306 0
A/Prof Nick Gottardo
Address 79306 0
Princess Margaret Hospital for Children
Roberts Road, Subiaco, Perth WA
6008
Country 79306 0
Australia
Phone 79306 0
+61 8 9340 8234
Fax 79306 0
Email 79306 0
Nick.gottardo@health.wa.gov.au
Contact person for public queries
Name 79307 0
Dr Kathryn Kinross
Address 79307 0
ANZCHOG Office
Hudson Institute of Medical Research,
27-31 Wright Street, Clayton VIC 3168
Country 79307 0
Australia
Phone 79307 0
+61 3 8572 2850
Fax 79307 0
Email 79307 0
kathryn.kinross@hudson.org.au
Contact person for scientific queries
Name 79308 0
A/Prof Nick Gottardo
Address 79308 0
Princess Margaret Hospital for Children
Roberts Road, Subiaco, Perth WA
6008
Country 79308 0
Australia
Phone 79308 0
+61 8 9340 8234
Fax 79308 0
Email 79308 0
Nick.gottardo@health.wa.gov.au