Trial Review

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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
1/12/2020
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
Scientific title
Post mortem tumour donation for Diffuse Intrinsic Pontine Glioma – developing DIPG cell cultures to test novel therapeutic strategies
Secondary ID [1] 281479 0
Nil
Universal Trial Number (UTN)
U1111-1136-5859
Trial acronym
HoTRODS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Pontine Glioma 287739 0
Diffuse Midline Glioma 312650 0
High grade glioma 312651 0
Condition category
Condition code
Cancer 288081 288081 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 285985 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288288 0
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
Timepoint [1] 288288 0
at the end of study
Primary outcome [2] 288289 0
harvest diffuse pontine glioma specimens, grow viable stem cells and culture new cell lines
Timepoint [2] 288289 0
at the end of the study
Secondary outcome [1] 299765 0
Nil
Timepoint [1] 299765 0
Nil

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with low grade gliomas

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2012
Actual
7/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment postcode(s) [1] 5929 0
2031
Recruitment postcode(s) [2] 5930 0
2145
Recruitment postcode(s) [3] 5931 0
2035
Recruitment postcode(s) [4] 5932 0
3051
Recruitment postcode(s) [5] 5933 0
5006
Recruitment postcode(s) [6] 5934 0
6008

Funding & Sponsors
Funding source category [1] 286249 0
Charities/Societies/Foundations
Name [1] 286249 0
Kids Cancer Alliance
Country [1] 286249 0
Australia
Primary sponsor type
Individual
Name
Dr. David Ziegler
Address
Centre for Children's Cancer and Blood Disorders
Sydney Children's Hospital
Level 1 High Street
Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 285052 0
None
Name [1] 285052 0
Address [1] 285052 0
Country [1] 285052 0
Other collaborator category [1] 277147 0
Charities/Societies/Foundations
Name [1] 277147 0
Kids Cancer Alliance
Address [1] 277147 0
Level 5
C25 Lowy Cancer Research Centre
Gate 9 High St
UNSW Sydney NSW 2052
Country [1] 277147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288326 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 288326 0
Research Ethics and Governance Unit
Locked Bag No.1
New Lambton, NSW 2035
Ethics committee country [1] 288326 0
Australia
Date submitted for ethics approval [1] 288326 0
28/03/2012
Approval date [1] 288326 0
12/07/2012
Ethics approval number [1] 288326 0
12/HNE/111

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34902 0
A/Prof David Ziegler
Address 34902 0
Kids Cancer Centre
Level 1, Sydney Children's Hospital
High St, Randwick, NSW 2031
Country 34902 0
Australia
Phone 34902 0
+61(0)2 9382 1730
Fax 34902 0
Email 34902 0
[email protected]
Contact person for public queries
Name 18149 0
A/Prof David Ziegler
Address 18149 0
Kids Cancer Centre, Level 1 South Wing, Sydney Children's Hospital, High Street Randwick, NSW 2031
Country 18149 0
Australia
Phone 18149 0
+61(0)2 9382 1730
Fax 18149 0
+61 (0)2 9382 1789
Email 18149 0
[email protected]
Contact person for scientific queries
Name 9077 0
A/Prof Dr. David Ziegler
Address 9077 0
Kids Cancer Centre, Level 1 South Wing, Sydney Children's Hospital, High Street Randwick, NSW 2031

Country 9077 0
Australia
Phone 9077 0
+61(0)2 9382 1730
Fax 9077 0
+61 (0)2 9382 1789
Email 9077 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
This is not covered by the current ethics application/approval


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.