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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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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
3/04/2024
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
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Scientific title
BRAIN: Development of a detailed database for collection of clinical data in patients with brain cancer.
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Secondary ID [1]
296728
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
BRAIN (Brain Registry Australia: Innovation and traNslation)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain Tumours
310592
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Condition category
Condition code
Cancer
309307
309307
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0
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Brain
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
5
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Target follow-up type
Years
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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.
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Intervention code [1]
313038
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
308270
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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.
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Assessment method [1]
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Timepoint [1]
308270
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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.
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Secondary outcome [1]
354480
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Overall survival of patients diagnosed with brain cancer in Australia after treatment. This outcome is being assessed from each patient’s medical record.
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Assessment method [1]
354480
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Timepoint [1]
354480
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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.
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with cerebral lymphoma will be excluded.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/02/2021
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Actual
18/02/2021
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Date of last participant enrolment
Anticipated
18/02/2026
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Actual
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Date of last data collection
Anticipated
18/02/2026
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Actual
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Sample size
Target
10000
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Accrual to date
8557
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12584
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
12585
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
12586
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [4]
12587
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St Vincent's Private Hospital - Fitzroy
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Recruitment hospital [5]
15157
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Southwest Health Care - Warrnambool - Warrnambool
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Recruitment hospital [6]
15158
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Royal Hobart Hospital - Hobart
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Recruitment hospital [7]
19255
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [8]
19256
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Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [9]
19257
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [10]
22195
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The Alfred - Melbourne
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Recruitment hospital [11]
22196
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Cabrini Hospital - Malvern - Malvern
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Recruitment hospital [12]
24362
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [13]
26352
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Epworth Richmond - Richmond
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Recruitment postcode(s) [1]
24959
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3050 - Parkville
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Recruitment postcode(s) [2]
24960
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3000 - Melbourne
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Recruitment postcode(s) [3]
24961
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3065 - Fitzroy
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Recruitment postcode(s) [4]
28452
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3280 - Warrnambool
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Recruitment postcode(s) [5]
28453
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7000 - Hobart
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Recruitment postcode(s) [6]
33835
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3220 - Geelong
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Recruitment postcode(s) [7]
33836
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3550 - Bendigo
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Recruitment postcode(s) [8]
33837
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3084 - Heidelberg
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Recruitment postcode(s) [9]
37349
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3144 - Malvern
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Recruitment postcode(s) [10]
39946
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3168 - Clayton
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Recruitment postcode(s) [11]
42326
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3121 - Richmond
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Funding & Sponsors
Funding source category [1]
301309
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Other Collaborative groups
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Name [1]
301309
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The Walter and Eliza Hall Institute of Medical Research
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Address [1]
301309
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IG Royal Parade
Parkville VIC 3052
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Country [1]
301309
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
The Walter and Eliza Hall Institute of Medical Research
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Address
IG Royal Parade
Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
301019
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None
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Name [1]
301019
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Address [1]
301019
0
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Country [1]
301019
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302050
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Melbourne Health, Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
302050
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Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
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Ethics committee country [1]
302050
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Australia
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Date submitted for ethics approval [1]
302050
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08/08/2018
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Approval date [1]
302050
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22/10/2018
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Ethics approval number [1]
302050
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HREC/44314/MH-2018
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
88962
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Dr Lucy Gately
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Address
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Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
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Country
88962
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Australia
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Phone
88962
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+61 3 9345 2555
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Fax
88962
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Email
88962
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[email protected]
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Contact person for public queries
Name
88963
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Ms Maria Edmonds
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Address
88963
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Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
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Country
88963
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Australia
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Phone
88963
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+61 3 9345 2896
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Fax
88963
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Email
88963
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[email protected]
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Contact person for scientific queries
Name
88964
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Ms Maria Edmonds
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Address
88964
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Gibbs Laboratory
Systems Biology & Personalised Medicine
The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade, Parkville, Victoria 3052
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Country
88964
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Australia
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Phone
88964
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+61 3 9345 2896
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Fax
88964
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Email
88964
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
593
Ethical approval
376476-(Uploaded-03-12-2018-14-09-25)-Study-related document.pdf
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.
Download to PDF