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Trial registered on ANZCTR
Registration number
ACTRN12612001183875
Ethics application status
Approved
Date submitted
31/10/2012
Date registered
7/11/2012
Date last updated
2/09/2024
Date data sharing statement initially provided
2/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Diffuse Brainstem Glioma Tumour Study: developing new treatment strategies for Diffuse Pontine Glioma
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Scientific title
Post mortem tumour donation for Diffuse Intrinsic Pontine Glioma – developing DIPG cell cultures to test novel therapeutic strategies
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Secondary ID [1]
281479
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Nil
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Universal Trial Number (UTN)
U1111-1136-5859
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Trial acronym
HoTRODS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Pontine Glioma
287739
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Diffuse Midline Glioma
312650
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High grade glioma
312651
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Condition category
Condition code
Cancer
288081
288081
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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
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a tumour biology study whereby tumour and constitutional tissue samples from participating sites in Australia with diffuse pontine glioma (DIPG) and other types of brainstem gliomas will be collected at autopsy, culture the DIPG cells in vivo and perform a screen of 10,000 small molecules that specifically inhibit diffuse pontine glioma propagation and identify these molecules to develop new treatment strategies for Diffuse Pontine Glioma.
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Intervention code [1]
285985
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Not applicable
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Comparator / control treatment
Nil
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
288288
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develop new treatment strategies for diffuse pontine glioma by culturing cells from autopsy specimens in vivo and identifying cells/molecules that inhibit the propagation of diffuse pontine glioma
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Assessment method [1]
288288
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Timepoint [1]
288288
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at the end of study
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Primary outcome [2]
288289
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harvest diffuse pontine glioma specimens, grow viable stem cells and culture new cell lines
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Assessment method [2]
288289
0
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Timepoint [2]
288289
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at the end of the study
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Secondary outcome [1]
299765
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Nil
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Assessment method [1]
299765
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Timepoint [1]
299765
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Nil
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Eligibility
Key inclusion criteria
1. Patients of any age with clinical and radiological diagnosis of diffuse brainstem glioma
OR
2. Patients with diffuse midline gliomas not involving the brainstem
OR
3. Patients with high grade gliomas in other locations
4. Patients with other histologies may be included only after discussion with the study chair
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Minimum age
No limit
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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
1. Patients with low grade gliomas
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
17/07/2012
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Actual
7/11/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment postcode(s) [1]
5929
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2031
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Recruitment postcode(s) [2]
5931
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2035
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Recruitment postcode(s) [3]
5930
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2145
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Recruitment postcode(s) [4]
5932
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3051
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Recruitment postcode(s) [5]
5933
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5006
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Recruitment postcode(s) [6]
5934
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6008
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Funding & Sponsors
Funding source category [1]
286249
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Charities/Societies/Foundations
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Name [1]
286249
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Kids Cancer Alliance
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Address [1]
286249
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Level 5
C25 Lowy Cancer Research Centre
Gate 9 High St
UNSW Sydney NSW 2052
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Country [1]
286249
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Australia
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Primary sponsor type
Individual
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Name
Dr. David Ziegler
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Address
Centre for Children's Cancer and Blood Disorders
Sydney Children's Hospital
Level 1 High Street
Randwick, NSW 2031
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Country
Australia
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Secondary sponsor category [1]
285052
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None
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Name [1]
285052
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Address [1]
285052
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Country [1]
285052
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Other collaborator category [1]
277147
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Charities/Societies/Foundations
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Name [1]
277147
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Kids Cancer Alliance
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Address [1]
277147
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Level 5
C25 Lowy Cancer Research Centre
Gate 9 High St
UNSW Sydney NSW 2052
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Country [1]
277147
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288326
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
288326
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Research Ethics and Governance Unit Locked Bag No.1 New Lambton, NSW 2035
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Ethics committee country [1]
288326
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Australia
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Date submitted for ethics approval [1]
288326
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28/03/2012
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Approval date [1]
288326
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12/07/2012
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Ethics approval number [1]
288326
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12/HNE/111
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Summary
Brief summary
The main goal of the study is to grow cells in the laboratory from tumours of patients with diffuse brainstem glioma and similar brainstem tumours. The aim of the results of the study is to help develop new and better treatments for patients with these types of tumours and help in choosing the right treatment for each patient and be able to predict which patients are more likely or not to respond to a certain type of treatment
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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
34902
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Prof David Ziegler
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Address
34902
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Kids Cancer Centre
Level 1, Sydney Children's Hospital
High St, Randwick, NSW 2031
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Country
34902
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Australia
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Phone
34902
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+61(0)2 9382 1730
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Fax
34902
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Email
34902
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d.ziegler@unsw.edu.au
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Contact person for public queries
Name
18149
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David Ziegler
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Address
18149
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Kids Cancer Centre, Level 1 South Wing, Sydney Children's Hospital, High Street Randwick, NSW 2031
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Country
18149
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Australia
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Phone
18149
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+61(0)2 9382 1730
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Fax
18149
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+61 (0)2 9382 1789
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Email
18149
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d.ziegler@unsw.edu.au
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Contact person for scientific queries
Name
9077
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Dr. David Ziegler
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Address
9077
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Kids Cancer Centre, Level 1 South Wing, Sydney Children's Hospital, High Street Randwick, NSW 2031
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Country
9077
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Australia
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Phone
9077
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+61(0)2 9382 1730
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Fax
9077
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+61 (0)2 9382 1789
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Email
9077
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d.ziegler@unsw.edu.au
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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
This is not covered by the current ethics application/approval
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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.
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