None listed
Conditions
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
Interventions
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 analysi
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.
Sponsors
Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG)
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
No minimum to 21 Years
Healthy volunteers
No
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 up to and including 21 years 4. Written informed consent
Exclusion criteria
nil
Outcome results
None listed