(1) Overview
Project description
Brain tumours, classified by cell origin and how the cells behave, range from least aggressive (benign) to most aggressive (cancer), with the most aggressive type (glioblastoma) being notoriously difficult-to-treat and despite improvements in detection and treatment, the number of deaths from these brain cancers has remained unchanged in the past 30 years [1].
The most aggressive form of brain cancer is currently treated using a multipronged approach that can involve surgery, radiotherapy and chemotherapy [2]. Yet the long-term outlook and survival rates of people with such cancers remains very poor (14.6 months) [3].
Current efforts in brain cancer research are to tailor treatments to the individual’s brain cancer however this can only be successful if there are reliable ways of identifying what is different about an individual’s brain cancer and adapting treatment to that difference.
In order to identify ways to personalise treatment and ensure individuals receive therapies that will benefit them the most and make a significant difference to their chances of beating brain cancer, procurement of high-quality samples is vital. Brain cancer research with real world impacts (translational) into the 1) identification of risk, 2) early detection, 3) sub-classification (including prognostics and predictive biomarkers), and 4) identification of new drug targets and treatments across a broad range of research fields, including molecular and cell biology, cancer genetics, clinical research and biomarker research heavily rely on the use of high-quality samples.
The proposed establishment of CTFBTB will collect, process, store, retrieve and disseminate high-quality samples and information for research projects following informed consent from participants diagnosed with brain tumours, ranging from the relatively benign pituitary adenomas and meningiomas through to the aggressive forms of brain cancer such as glioblastoma and gliosarcoma.
Together, the proposed collection and processing of these samples, with the data that would be made available for use to the research community, not only increases the utility of these samples but also increases research information that can be obtained, increases the rate of research and accelerates research findings to benefit brain tumour patients.
Classification (1)
Human.
Species
Homo sapiens.
Classification (2)
Biological samples and associated clinical and research data.
Context
Spatial coverage
CTFBTB collects biospecimens from a single site: Prince of Wales Private Hospital, Randwick Sydney NSW, Australia. Coordinates are as follows Latitude: -33.921290 and Longitude: 151.239470.
Temporal coverage
Start date 08 January 2019 to present; with collection, processing and storage of biospecimens approved until 24 September 2029.
(2) Methods
Consenting and Material Handling Procedures
Recruitment Protocol
Participating clinicians (as listed in this protocol) are responsible for identifying participants that would be suitable to contribute to the CTFBTB.
Those participants identified are then contacted by the Biobank Co-Ordinator or Co-Investigator in order to obtain informed consent.
Informed consent is obtaining using the CTFBTB’s participant information sheets and consent forms. The participant information sheets outline in easy to understand language with diagrams, the proposed use of the samples, the risks and benefits to the participant and what participation involves. The consent forms are designed to collect, process and store samples for broad and as yet unspecified research into brain cancer. The CTFBTB uses 3 types of participant information sheets and consent forms depending on the participant and their mental capacity, that is, self, parent/guardian and assent.
A revocation of consent form is to be completed should a participant wish to withdraw from the study. Upon revocation, any of the participants specimens and information that remain in the bank will be destroyed.
If the Biobank Co-Ordinator or Co-Investigator is successful at obtaining informed consent, then the samples, including fresh tumour tissue, blood and other relevant bodily fluids as listed in Table 1, are collected at time of surgical resection.
Fresh tumour tissues are collected in conjunction with the anatomical pathology department of the participating hospital with qualified pathologists and only fresh tumour tissue which is deemed in excess of diagnostic requirements are stored securely and anonymously by the CTFBTB.
All data as listed in Table 1 (if available) is recorded electronically, using the Biobanking software, OpenSpecimen.
Table 1
A summary of the characteristics of Charlie Teo Foundation Brain Tumour Bank.
| CHARACTERISTIC | DESCRIPTION | ||
|---|---|---|---|
| Sample | Tumour Type | Brain Tumour defined according to 2016 WHO classification system [4] | |
| Collection | Collection Site | Centre for Minimally Invasive Neurosurgery, Prince of Wales Private Hospital, Sydney Australia | |
| Sample Collection Type | Tumour Tissue | ||
| Peripheral Blood | |||
| Cerebrospinal Fluid* | |||
| Demographic Data | |||
| Clinical Data | Pathological Data | ||
| Imaging Data | |||
| Quality of Life (QoL) Data | |||
| Processing | Sample Processing | Fresh Frozen Tumour Tissue | |
| Whole Blood | |||
| Guthrie Card | |||
| Plasma | |||
| Serum | |||
| Buffy Coat | |||
| Peripheral Blood Mononuclear Cell (PBMC) | |||
| Formalin-Fixed Paraffin Embedded Tissue (FFPE) | |||
| Haematoxylin & Eosin (H&E) Cryosections | |||
| Fixed Tissue Other | Non-aldehyde fixative agents | ||
| Cell Line Culture | |||
| Whole Genome Sequencing Data | |||
| Whole Transcriptome Sequencing Data | |||
| Whole Exome Sequencing Data | |||
| Single-Cell DNA Sequencing Data | |||
| Single-Cell RNA Sequencing Data | |||
| Storage | Sample Storage Facilities | Long-Term | Garvan Institute of Medical Research |
| Short-Term (if required) | Centre for Minimally Invasive Neurosurgery, Prince of Wales Private Hospital, Sydney Australia | ||
| Data Storage Facilities | OpenSpecimen | ||
| Other | Source of Associated Data | Hospital Medical & Pathology Records | |
| Local Health Districts and NSW Cancer Registries | |||
| Attending Clinicians Consult Rooms | |||
| Participants | |||
| Source of Other samples and data | Steve and Lynette Waugh Brain Tumour Bank | ||
The standard work procedures implemented by CTFBTB have been formulated based on several best practice guidelines, which include the International Society for Biological and Environmental Repositories (ISBER) Best Practices for Repositories Guidelines and the Organisation for Economic Co-operation and Development (OECD) Best Practice Guidelines for Biological Resources Centres and ISO 20387 – Biotechnology – Biobanking – General Requirement for biobanking.
Stabilization/preservation
Fresh tumour tissue are stabilized on ice at 4°C before fixation in formalin, non-aldehyde fixative agent, or medium to allow the establishment of cell line culture; or snap freezing in liquid nitrogen. Blood specimens and other bodily fluids are stabilized at 4°C before long-term preservation at –80°C or –196°C with the exception of plasma samples which are stabilized in vacutainers of EDTA and stabilized at 4°C prior to long-term preservation [5].
Type of long-term preservation
Please see section (3) Bioresource description, Biospecimen type for details.
All biospecimens and information are stored securely and anonymously.
Storage temperature
Please see section (3) Bioresource description, Biospecimen type for details.
Shipping temperature from patient/source to preservation or research use
Biospecimens are transported using temperature-controlled, cold chain solutions [5]. Depending on the biospecimen type to be transported and the transportation logistics, several options may be available including:
Controlled ambient → +15°C to +25°C
Refrigerated → +2°C to +8°C
Frozen → –20°C
Deep frozen → –70°C
Packed on liquid nitrogen → –196°C
Shipping temperature from storage to research use
Biospecimens are transported using temperature-controlled, cold chain solutions [5]. Depending on the biospecimen type to be transported and the transportation logistics, several options may be available including:
Controlled ambient → +15°C to +25°C
Refrigerated → +2°C to +8°C
Frozen → –20°C
Deep frozen → –70°C
Packed on liquid nitrogen → –196°C
Quality assurance measures
CTFBTB is a NSW Health Pathology certified Biobank with its processes and procedures compliant with ISO 20387 – Biotechnology – Biobanking – General Requirement for biobanking. It has a quality management system that comprises quality assurance and quality control protocols, designed with the purpose to ensure that all relevant biobanking activities are not compromised by human or processing error as well as to ensure the sustainability of CTFBTB. Detailed Safe Work Procedures (SWPs) which provide step-by-step accurate descriptions of specific tasks ensure that all samples are handled consistently and correctly.
Quality Assurance
The quality assurance measures that are implemented by CTFBTB include:
Implementation of SWPs
Personnel training; documented and updated, if required, on a periodic basis
Documentation of modifications or revisions of SWPs and risks assessments (RAs)
Maintenance of records pertaining to samples, equipment, and consumables
Quality Control
The quality control measures implemented by CTFBTB include:
Verification of samples by a pathologist
Validation of processing methods of samples via literature reviews, end user feed-back and/or laboratory quality control results
Internal sample testing, checking RNA Integrity Number.
Source of associated data
Sources of associated data include:
Hospital medical and pathology records
Local health district and NSW Cancer registries
Attending clinicians consult rooms
Participants
Ethics Statement
Ethics approval is obtained from Bellberry Limited, SA, Australia, [2019-08-682], in accordance with the guidelines of the National Health and Medical Research Council of Australia’s National Statement on Ethical Conduct in Human Research.
Constraints
Current constraints include uncommon disease condition.
(3) Bioresource description
Object name
Brain Cancer
Bioresource name
Charlie Teo Foundation Brain Tumour Bank
Bioresource acronym: CTFBTB
Bioresource location
The central site of CTFBTB is located at Charlie Teo Foundation, 605 Botany Road, Rosebery NSW 2018, Australia.
Bioresource contact
Bioresource URL
Bioresource type
Brain Cancer
Type of sampling
Disease based
Anatomical site
Brain
Disease status of patients/source
Cancer
Clinical characteristics of patients/source:
Age: all ages
Gender: males and females
Treatment information: yes
Inclusion criteria: ability of participant to give informed consent
Stage of the disease at time of collection: Biospecimens are collected at the time of surgical resection
Size of the bioresource
Over 600 participants as at 25 January 2021
Ongoing recruitment of approximately 100 participants per annum
Collection of biospecimens is ongoing and indefinite
Vital state of patients/source
Alive
Clinical diagnosis of patients/source
Brain Cancer
Pathology diagnosis
Brain Tumour defined according to 2016 WHO classification system [4].
Biospecimen type
A summary of the biospecimen characteristics is provided below (Table 1).
Release date
The date at which biospecimens have been available for applications is 2019.
Access criteria
Principles of Access
Biospecimens collected by CTFBTB are made available to researchers on the provision that use of samples are for scientifically valid and ethically approved research projects.
Prior to applying to CTFBTB, the investigator is encouraged to contact the Biobank to discuss sample availability and other relevant information.
The investigator will submit a completed ‘Charlie Teo Foundation Brain Tumour Bank Researcher Application Form’, which will be available on request from Charlie Teo Foundation, along with their ethics application and ethics approval and/or amendment letter(s), CV of the principal investigator and Material Transfer Agreement (MTA), which will be received by CTFBTB Co-Ordinator.
CTFBTB Co-Ordinator will notify the Head of Research who will convene the Biobank Committee, who will assess the application.
If the application is approved, Charlie Teo Foundation will formally notify the investigator and forward an MTA (if not already completed), to which the investigator must sign and return.
Once receipt of the signed MTA has been received by Charlie Teo Foundation, the samples (non-identifiable) will be packaged and shipped to the investigator.
Material Transfer Agreement
The MTA governs the supply of materials (defined as samples and data), use of the materials, reporting and access, intellectual property rights, including commercialization provisions, the use and survival of materials in relation to confidentiality, liability and indemnity. The MTA is entered into where CTFBTB material is transferred to an organisation for the purposes of that organisation’s own research. Once receipt of the signed MTA has been received by CTFBTB, then the samples will be packaged and shipped to the researcher.
(4) Reuse potential
CTFBTB does not request return of samples but should be informed about research results. The CTFBTB encourages, where possible, sharing of materials created from the use of samples, which may include whole genome, exome or single-cell RNA sequencing data and validated protein expression data.
Acknowledgements
Charlie Teo Foundation.
Funding statement
CTFBTB was established with support of Charlie Teo Foundation More Data Grant.
Competing Interests
The authors have no competing interests to declare.
Author Contributions
Nicole J. Caixeiro, Curator
Joseph W. Po, Co-Curator
Ashraf Zaman, Co-ordinator
Michael E. Sughrue, Co-Investigator
Charles Teo, Creator