Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000884505
Ethics application status
Approved
Date submitted
6/06/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
BrainPOP Precision: Implementation of precision medicine into the care of patients with brain cancers
Scientific title
BrainPOP Precision: Evaluating the feasibility and impact of the implementation of precision medicine into the care of patients with brain cancers
Secondary ID [1] 312133 0
None
Universal Trial Number (UTN)
Trial acronym
BrainPOP Precision
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain cancer
 333776 0
Central nervous system cancer 333778 0
Glioblastoma 333782 0
Condition category
Condition code
Cancer 330451 330451 0 0
Brain
Cancer 330777 330777 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

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.
Intervention code [1] 328728 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338402 0
Establish feasibility of collection of fresh tissue(s), CSF, and plasma for molecular analyses at critical clinical junctures including diagnosis, treatment response, progression, and relapse. This will be assessed as a composite outcome.
Timepoint [1] 338402 0
Following result of molecular profiling analyses, following treatment and, if applicable, following progression.
Primary outcome [2] 338403 0
Understand the impact of in-depth molecular analysis of CNS tumours on clinical decision-making and patient outcomes.
This will be assessed as a composite outcome.
Timepoint [2] 338403 0
Following result of molecular profiling analyses, following treatment and, if applicable, following progression or death.
Primary outcome [3] 338404 0
Change in clinical management through improved diagnostic and prognostic tools by integrating molecular knowledge, histopathology, and radiomics.
Timepoint [3] 338404 0
Following result of molecular profiling analyses, following treatment and, if applicable, following progression or death.
Secondary outcome [1] 435804 0
Evaluate the feasibility of expediting the clinical testing of rational therapeutic hypotheses in patients with CNS cancers.
Timepoint [1] 435804 0
Following result of molecular profiling analyses, following treatment and, if applicable, following progression or death.
Secondary outcome [2] 435805 0
Identify potential biomarkers of treatment response and resistance (this will be assessed as a composite measure).
Timepoint [2] 435805 0
Following result of molecular profiling analyses, following treatment and, if applicable, following progression or death.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide informed consent.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/07/2024
Date of last participant enrolment
Anticipated
25/06/2027
Actual
Date of last data collection
Anticipated
25/06/2027
Actual
Sample size
Target
300
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26632 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 42672 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 316493 0
Government body
Name [1] 316493 0
VicGov (The Brain Cancer Centre Brain Perioperative Clinical Trial Program (BrainPOP))
Country [1] 316493 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 318666 0
None
Name [1] 318666 0
Address [1] 318666 0
Country [1] 318666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315287 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315287 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 315287 0
Australia
Date submitted for ethics approval [1] 315287 0
04/12/2023
Approval date [1] 315287 0
10/04/2024
Ethics approval number [1] 315287 0
23.243

Summary
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.
Trial website
https://www.thebraincancercentre.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134230 0
Dr Jim Whittle
Address 134230 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000 Australia
Country 134230 0
Australia
Phone 134230 0
+61 3 8559 7456
Fax 134230 0
Email 134230 0
[email protected]
Contact person for public queries
Name 134231 0
Richelle Linklater, Parkville Cancer Clinical Trials Unit
Address 134231 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000 Australia
Country 134231 0
Australia
Phone 134231 0
+61 3 8559 7456
Fax 134231 0
Email 134231 0
[email protected]
Contact person for scientific queries
Name 134232 0
Jim Whittle
Address 134232 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000 Australia
Country 134232 0
Australia
Phone 134232 0
+61 3 8559 5000
Fax 134232 0
Email 134232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.