Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001182583
Ethics application status
Approved
Date submitted
29/09/2015
Date registered
3/11/2015
Date last updated
3/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The AGOG (Australian Genomics and Clinical Outcomes of Glioma) Epidemiology Study - investigating lifestyle and environmental exposures and genetic variants and glioma risk in those with and without glioma.
Scientific title
Observational Study investigating lifestyle and environmental exposures, genetic variants and glioma risk in those with and without glioma.
Secondary ID [1] 287565 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
AGOG (Australian Genomics and Clinical Outcomes of Glioma)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioma 296346 0
Condition category
Condition code
Cancer 296622 296622 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The AGOG Epidemiology Study is a hospital-based family-case-control study of glioma, collecting estimates of lifestyle, constitutional, and environmental exposures and sampling blood for genotyping and future biomarker studies. This is a retrospective observational study only - no intervention is being tested. Participants complete 3 questionnaires at one time and provide one blood sample.
Intervention code [1] 292967 0
Not applicable
Comparator / control treatment
We will recruit an UNAFFECTED same sex sibling (or half sibling) closest in age to the case AND a spouse/partner. If this is unsuccessful, we will aim to recruit an UNAFFECTED same sex sibling (or half sibling) next closest in age AND a spouse/partner. The controls will complete the same questionnaires for comparison as the case and provide a blood sample.
Control group
Active

Outcomes
Primary outcome [1] 296236 0
Lifestyle risk factors for glioma, assessed by the AGOG Epidemiology Study Participant Health and Lifestyle Questionnaire which was designed specifically for this study.
Timepoint [1] 296236 0
Participants complete three questionnaires once upon enrolment.
Primary outcome [2] 296237 0
Genetic risk of glioma, assessed using a family history of cancer questionnaire (designed specifically for this study) and genetic data from a blood or saliva sample sample.
Timepoint [2] 296237 0
DNA samples are collected once upon enrolment..
Primary outcome [3] 296239 0
Collect histopathological reports at consent from recruiting doctor to collect archival tissue to identify new prognostic factors.
Timepoint [3] 296239 0
At participant consent.
Secondary outcome [1] 317906 0
Nil
Timepoint [1] 317906 0
Nil

Eligibility
Key inclusion criteria
Case:
1. aged 18 to 79 years
2. diagnosed with glioma (including low and high grade glioma) between January 2013 and December 2016 with histopathological confirmation.
Control:
1. Aged of 18 and over the age of 79.
2. Never been diagnosed with glioma
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Case
1. Non-residents of Australia.
2. Patients who are unable to provide written informed consent, or who are deemed by their clinician to be significantly cognitively impaired, and who do not have a person responsible to provide substitute consent on their behalf.
3. Patients who are unable to complete the questionnaires themselves in English.
4. Patients under the age of 18 and over the age of 79.
Control
1. Individuals who are unable to complete the questionnaires themselves in English.
2. Individuals under the age of 18 and over the age of 79.
3. Have been diagnosed with glioma

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/08/2013
Date of last participant enrolment
Anticipated
31/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292130 0
Government body
Name [1] 292130 0
Cancer Australia
Country [1] 292130 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Australia
Address
Level 14, 477 Pitt Street,
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 290807 0
Charities/Societies/Foundations
Name [1] 290807 0
Cancer Council Victoria
Address [1] 290807 0
615 St Kilda Road, Melbourne VIC 3004
Country [1] 290807 0
Australia
Secondary sponsor category [2] 290809 0
Charities/Societies/Foundations
Name [2] 290809 0
Cancer Council New South Wales
Address [2] 290809 0
153 Dowling Street, Woolloomooloo NSW 2011
Country [2] 290809 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293608 0
Cancer Council Victoria HREC
Ethics committee address [1] 293608 0
615 St Kilda Road Melbourne VIC 3004
Ethics committee country [1] 293608 0
Australia
Date submitted for ethics approval [1] 293608 0
Approval date [1] 293608 0
14/06/2012
Ethics approval number [1] 293608 0
HREC1208
Ethics committee name [2] 293609 0
Melbourne Health HREC
Ethics committee address [2] 293609 0
PO Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [2] 293609 0
Australia
Date submitted for ethics approval [2] 293609 0
Approval date [2] 293609 0
09/07/2013
Ethics approval number [2] 293609 0
2013.085
Ethics committee name [3] 293610 0
Northern Sydney Local Health District
Ethics committee address [3] 293610 0
Research Office
Kolling Building, Level 3
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [3] 293610 0
Australia
Date submitted for ethics approval [3] 293610 0
Approval date [3] 293610 0
28/03/2013
Ethics approval number [3] 293610 0
0809-198M

Summary
Brief summary
The AGOG Epidemiology Study will study genes, lifestyle and environmental factors in people with and without brain tumours in order to identify who are at risk of developing these tumours.
Who is it for? You may be eligible to join this study if you are aged 18 to 79 years and were diagnosed with glioma between January 2013 and June 2016.
Study details This is an observational study, meaning that no treatment is given to participants as part of this study. Participants and up to two family members are asked to provide a blood (or saliva) sample and complete three questionnaires regarding their lifestyle and family history of glioma. Researchers will use this information, along with disease and treatment information from hospital records to identify patterns between patient lifestyles, family histories, genetics and disease treatment and outcomes. It is hoped that the findings of this study will provide a research platform for further studies into predictive factors of glioma and glioma outcomes, and for the identification of future treatment options for glioma.
Trial website
http://agogbio.unsw.edu.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60674 0
A/Prof Claire Vajdic
Address 60674 0
Cancer Epidemiology Research Unit
Centre for Big Data Research in Health
Level 1, AGSM Building
UNSW Australia
Sydney NSW 2052
Country 60674 0
Australia
Phone 60674 0
+61 2 9385 1424
Fax 60674 0
Email 60674 0
[email protected]
Contact person for public queries
Name 60675 0
Ms Jennifer Walsh
Address 60675 0
Cancer Epidemiology Research Unit
Centre for Big Data Research in Health
Level 1, AGSM Building
UNSW Australia
Sydney NSW 2052
Country 60675 0
Australia
Phone 60675 0
+61 29385 9333
Fax 60675 0
Email 60675 0
[email protected]
Contact person for scientific queries
Name 60676 0
A/Prof Kerrie McDonald
Address 60676 0
The Cure Brain Cancer Neuro-oncology Laboratory
Level 2
Lowy Cancer Centre
UNSW Australia
Sydney NSW 2052
Country 60676 0
Australia
Phone 60676 0
+61 2 9385 1471
Fax 60676 0
Email 60676 0
[email protected]

No information has been provided regarding IPD availability


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
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