None listed
Conditions
Brief summary
This study involves real-time molecular profiling of brain or other CNS tumours by analysing tumour tissue, cerebrospinal fluid (CSF), and blood plasma at critical points throughout cancer diagnosis, treatment, and recurrence. Molecular profiling is like taking a detailed snapshot of a tumour's genetic makeup, helping doctors identify specific changes or mutations to guide effective treatment choices. Who is it for? You may be eligible for this study if you are a male or female age 18 or older with a known or strong suspicion of primary CNS cancer, suitable for systematic treatment. Study details Biospecimens including tumour tissue, blood and cerebrospinal fluid (CSF) will be collected longitudinally from participants during routine care procedures and/or by accessing stored material. Clinical data will be collected throughout the study. Biospecimens collected will be molecularly profiled. Molecular profiling analysis will include targeted panel sequencing, whole genome transcriptome sequencing and methylation array using tumour tissue samples. Results will be returned to the treating clinicians, accompanied by interpretation and recommendations from the molecular tumour board. By integrating clinical, molecular, histopathological, and radiological data, the project seeks to improve patient outcomes and establish feasibility of molecular profiling in CNS tumours.
Interventions
Molecular profiling will be completed on participant's tumour tissue samples taken during routine operations. CSF will be taken during the same operations where safe and feasible. Participants may opt-in to an additional consent of lumbar puncture for collection of CSF where deemed appropriate by the treating clinician, however this is not required and is optional. Blood samples will be taken longitudinally at enrolment, throughout treatment and during follow up.
BrainPOP Precision aims to deli
Molecular profiling will be completed on participant's tumour tissue samples taken during routine operations. CSF will be taken during the same operations where safe and feasible. Participants may opt-in to an additional consent of lumbar puncture for collection of CSF where deemed appropriate by the treating clinician, however this is not required and is optional. Blood samples will be taken longitudinally at enrolment, throughout treatment and during follow up. BrainPOP Precision aims to deliver prospective real time molecular characterisation of CNS tumours. Biospecimens including tumour tissue, blood and cerebrospinal fluid (CSF) will be collected longitudinally from participants during routine care procedures and/or by accessing stored material. Clinical data will be collected from the ethically-approved registry BRAIN (Brain tumour Registry Australia INnovation and translation registry). Biospecimens collected will be molecularly profiled. Molecular profiling analysis will include targeted panel sequencing, whole genome transcriptome sequencing and methylation array using tumour tissue samples. Results will be returned to the treating clinicians, accompanied by interpretation and recommendations from the molecular tumour board. Molecular profiling may be repeated if a participant recurs/progresses while on trial and has available associated biospecimens. Participant involvement that is additional to standard of care for this study includes blood sample collections during routine clinical appointments (anticipated to take less than 10 minutes, but do require participants to be at the site) and potential discussion with the treating clinician to discuss the results of molecular profiling analyses (at clinician discretion). Additionally, if a participant consents to lumbar puncture for CSF collection, this would involve additional involvement determined by the treating clinician. The observation period for this study spans from the time of enrolment until the participant's death or end of study.
Sponsors
Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with known, or strong clinical suspicion, of primary CNS cancer. 2. The patient, or patient’s parent/guardian, has given written informed consent (and assent, as applicable) 3. Suitable for systemic treatment. 4. ECOG (Eastern Cooperative Oncology Group) performance status less than or equal to 2 5. Estimate life expectancy greater than 6 months. 6. Access to appropriate sample(s) for molecular testing.
Exclusion criteria
1. Unable to provide informed consent.
Outcome results
None listed