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Trial registered on ANZCTR


Registration number
ACTRN12618001959268
Ethics application status
Approved
Date submitted
29/11/2018
Date registered
4/12/2018
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
BRAIN: Development of a detailed database for collection of clinical data in patients with brain cancer
Scientific title
BRAIN: Development of a detailed database for collection of clinical data in patients with brain cancer.
Secondary ID [1] 296728 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BRAIN (Brain Registry Australia: Innovation and traNslation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumours 310592 0
Condition category
Condition code
Cancer 309307 309307 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The follow-up period is 5 years. No additional tests are required, all data will be collected from the medical record of patients with histologically confirmed brain tumours. Data captured will include presentation and disease characteristics, surgical interventions, prescription of system therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting.
Intervention code [1] 313038 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308270 0
Proportion of patients diagnosed with brain cancer in Australia that are recurrence-free after treatment. This outcome is being assessed from each patient's medical record.
Timepoint [1] 308270 0
Data will be collected at up to 6 time points for a maximum of 5 years; diagnosis, surgery, chemotherapy, radiotherapy, surveillance, and recurrence. Primary time point is at the end of the 5 year data collection period.

Secondary outcome [1] 354480 0
Overall survival of patients diagnosed with brain cancer in Australia after treatment. This outcome is being assessed from each patient’s medical record.
Timepoint [1] 354480 0
Data will be collected at up to 6 time points for a maximum of 5 years; diagnosis, surgery, chemotherapy, radiotherapy, surveillance, and recurrence. Timepoint is at the end of the 5 year data collection period.

Eligibility
Key inclusion criteria
Histologically confirmed brain tumours including but not limited to glioma, meningioma, brain metastases and rare tumours including medulloblastoma and ependymoma.
Adults aged 18 years and above.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cerebral lymphoma will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
In order to compare clinical outcomes across different subgroups, KaplanMeier
survival curves will be defined from survival data and constructed using SAS® software (SAS Institute Inc., Cary, NC, USA). The stratified log rank test will be used to compare survival curves between different groups of participants. Pvalues of 0.05 will be considered
significant. Due to the nonrandomised nature of such comparisons propensity score techniques will be used to balance comparison groups according to baseline factors.

Recruitment
Recruitment status
Not yet 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] 12584 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 12585 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 12586 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [4] 12587 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 24959 0
3050 - Parkville
Recruitment postcode(s) [2] 24960 0
3000 - Melbourne
Recruitment postcode(s) [3] 24961 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301309 0
Other Collaborative groups
Name [1] 301309 0
The Walter and Eliza Hall Institute of Medical Research
Address [1] 301309 0
IG Royal Parade
Parkville VIC 3052
Country [1] 301309 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
IG Royal Parade
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 301019 0
None
Name [1] 301019 0
Address [1] 301019 0
Country [1] 301019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302050 0
Melbourne Health, Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 302050 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 302050 0
Australia
Date submitted for ethics approval [1] 302050 0
08/08/2018
Approval date [1] 302050 0
22/10/2018
Ethics approval number [1] 302050 0
HREC/44314/MH-2018

Summary
Brief summary
The aim of this study is to establish a comprehensive clinical registry for patients with brain tumours in Australia.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a brain tumour.

Study details
Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. All enrolled patients will have clinical data collected for up to 5 years. Data captured will include presentation and the disease course of brain tumours, surgical interventions, prescription of system therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting.

This registry will help to describe the current practice patterns and identify any deficiencies or abnormalities. By doing so, we can ensure that Australian brain tumour patients receive the best care possible.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88962 0
Dr Lucy Gately
Address 88962 0
Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
Country 88962 0
Australia
Phone 88962 0
+61 3 9345 2555
Fax 88962 0
Email 88962 0
gately.l@wehi.edu.au
Contact person for public queries
Name 88963 0
Ms Maria Edmonds
Address 88963 0
Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
Country 88963 0
Australia
Phone 88963 0
+61 3 9345 2896
Fax 88963 0
Email 88963 0
Maria.Edmonds@mh.org.au
Contact person for scientific queries
Name 88964 0
Ms Maria Edmonds
Address 88964 0
Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
Country 88964 0
Australia
Phone 88964 0
+61 3 9345 2896
Fax 88964 0
Email 88964 0
Maria.Edmonds@mh.org.au

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?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 593 0
Ethical approval
Citation [1] 593 0
Link [1] 593 0
Email [1] 593 0
Other [1] 593 0
Summary results
No Results