AGOG Research
Priorities, Aims and Outcomes
Who will be asked to participate?
Patients at AGOG recruitment centres will be asked to participate if they have a confirmed histopathological diagnosis of glioma, or if it is likely that have glioma based on their clinical and imaging tests, and if they can give informed consent.
What will be asked of patients?
Participants in AGOG will be asked to consent to 3 steps:
- Donation of a blood sample for extraction of DNA, RNA, serum and plasma
- Donation of a tumour tissue sample at time of surgery, or access to archived tissue samples
- Completion of a brief questionnaire looking at family history, occupation, ethnicity
AGOG is very keen not to burden glioma patients, their families and carers, nor to interfere in any way with their primary care.
Privacy
AGOG participants will be given clear information about the storage of biospecimens and confidentiality procedures. Participants who withdraw from this study will have the option to have their samples destroyed, and AGOG will not release any information to a third party without the participant's consent, except as required by law.
All clinical data, blood, tissue and DNA samples will be stored in secure facilities governed by international best-practice standards. All samples will be labeled by study number only, with the only linkage to participant information via a secure, password protected database. The limited number of research staff who are able to access identifiable data will sign a covenant of confidentiality and will comply with relevant state and institutional privacy laws. Any relevant hard-copy information will be stored in a locked area of the individual recruitment sites.
Consent to participate in AGOG will include consent for access to participants' blood samples by researchers working in brain tumour and related cancer research, who meet stringent ethical and access requirements. These studies will need to be approved both by a Human Research Ethics Committee as well as an AGOG National Advisory Board comprising eminent clinical and community representatives who are independent from the project. Any researchers based overseas will be required to demonstrate that they similarly meet the appropriate Australian standards of ethics and privacy.
Expertise
The AGOG Scientific Team is multidisciplinary and has demonstrated strengths in both clinical and basic science research. Each of the participating scientists and clinicians have experience and demonstrated success in the strategic integration of scientific research and clinical practice, including the integration of disease specific clinical data collections with biospecimen storage, genetic and statistical interpretation.
Each of our AGOG leaders has a strong vision for development of this research program, and all have a good track record in developing and managing research teams to an internationally competitive level.
The AGOG team is thus very well placed to facilitate research into the natural history, genetics, treatment response and outcomes of patients with glioma in Australia.
Importance of establishing AGOG
The central challenge to glioma research is to provide "strong evidence" on which treating clinicians and patients can base their choice of treatment plan. "Strong evidence" requires well designed, adequately powered and validated research and clinical trials. The recruitment of adequate numbers of clinically well-characterized patients, with associated biospecimens from glioma patients in NSW and WA and ultimately, all of Australia, will address the issue of statistical power. The standardization of multi-disciplinary clinical data will start this ongoing process of well-designed research.
Resources and Facilities
Tissue Banking
Tumour banks are a critical engine for basic, clinical and translational research for all cancers. The availability of preserved tumour samples (in excess of requirements for histopathological assessment) is pivotal to the genomics revolution in regard to how we diagnose and treat brain tumours.
As part of AGOG, tumour tissue (fresh frozen or paraffin block) will be collected from all consenting adult patients with glioma at each participating site, with central tissue storage at the Kolling Institute's Australasian Brain Tumour Bank (ABTB) in Sydney.
Blood and DNA Banking
Whole blood will be collected from all consenting adult patients with glioma at all participating sites, with central storage at the WA DNA Bank (WADB) in Perth. DNA, RNA, serum, plasma will also be extracted and stored at the WADB and Kolling Institute.
The WADB is funded by the Federal Government and provides scientists with a state-of-the-art, highly secure facility to store DNA samples needed to undertake critical medical research into common diseases such as cancer, asthma, diabetes and heart disease.
A direct outcome of AGOG is to found the Australian Glioma DNA Bank (AGDB) and together with the ABTB, extend this into a national and international resource for the brain tumour research community.
Clinical Data and Biospecimen Tracking
All data will be stored centrally within the WA Genetic Epidemiology Resource (WAGER), which integrates clinical, epidemiological and genetic resources with biospecimen banks, provides tools and computing infrastructure to simplify and reduce the workload associated with study conduct, and improves the quality and accessibility of the data collected.
Blood, DNA and Tissue samples collected as part of AGOG will be managed via the WAGER Laboratory Information Management System (LIMS).
For both the WADB and WAGER, data custodianship remains with the original investigators at each site at all times.
