The Rainbows for Kate Australian Sarcoma Kindred Study
Study Manager
Dr Mandy Ballinger, Peter MacCallum Cancer Centre, Victoria
Contact sarcoma@petermac.org
Overview
Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged, and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses.
The Rainbows for Kate Australian Sarcoma Kindred Study aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma.
Potential study participants will be identified at key sarcoma clinics, asked to complete a questionnaire and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. Participant recruitment is anticipated to begin mid 2009 in Victoria and roll out to NSW and Queensland by the end of the year. The ongoing nature of this project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes.
Progress so far…
Across Australia, five major sarcoma clinics were identified as optimal sites for the initial phase of the RFK ASK Study, namely the Peter MacCallum Cancer Institute in Melbourne, the Prince of Wales and Royal Prince Alfred Hospitals in Sydney and the Princess Alexandra and Wesley Hospitals in Brisbane. The RFK ASK Study Steering committee has been formed to include key people from each of these sites as well as others with wide ranging expertise.
Steering Committee Members
David Thomas, Medical Oncologist & Laboratory Head, PMCC, Melbourne
Gillian Mitchell, Director, PMCC Familial Cancer Centre, Melbourne
Heather Thorne, kConFab National Manager, PMCC, Melbourne
John Hopper, Director, Centre for MEGA Epidemiology, University of Melbourne
Jayesh Desai, Consultant Medical Oncologist, Royal Melbourne Hospital, Melbourne
Loane Skene, Professor and Program Director, Faculty of Law, University of Melbourne
Craig Lewis, Senior Oncologist, Prince of Wales Hospital, Sydney
Kathy Tucker, Head, Hereditary Cancer Clinic, Prince of Wales Hospital, Sydney
Martin Tattersall, Head, Department of Medical Oncology, Royal Prince Alfred Hospital, Sydney
Sandro Porceddu, Senior Radiation Oncologist, Princess Alexandra Hospital, Brisbane
Michael Gattas, Clinical Geneticist, Genetic Health Queensland
Ian Dickinson, Orthopaedic Surgeon, The Wesley Hospital, Brisbane
Mary-Anne Young, Genetic Counsellor, PMCC Familial Cancer Centre, Melbourne
In January, the inaugural Steering Committee meeting was held in Melbourne and was crucial to the planning and implementation of the study over the coming months. At the meeting, an overall ethical plan for the study was well refined, site specific operational strategies were discussed and key study elements such as the participant questionnaire, were decided. Timelines were put in place to roll out ethics applications in the various states.
Human Research Ethics approval is mandatory for each site at which the study wishes to function. In the case of the RFK ASK Study this means four applications to four Human Research Ethics Committees (HRECs) to cover the five sites of operation. The first application was submitted to the Peter MacCallum Cancer Institute HREC in February and after a favourable review, approval was granted in early April, a very significant milestone for the study. It is anticipated that participant recruitment will start in Victoria, in July.
The RFK ASK Study is fortunate to be able to utilise the very experienced Research Nurses already engaged in the kConFab program. kConFab is a consortium of researchers investigating the familial aspects of breast cancer and is centralised operationally at the Peter MacCallum Cancer Institute. kConFab have been, and continue to be, extremely supportive of the RFK ASK Study and this support has fast tracked initiation of the study immensely. The Research Nurses play a crucial role in recruiting, interviewing and following up study participants. A sarcoma/RFK ASK Study specific information pack has been put together for the Research Nurses that will be assisting with the RFK ASK Study as a familiarisation tool and an introduction to the project.
The RFK ASK Study has again been able to capitalise on the experience of kConFab and adopt the current kConFab laboratory protocols for biospecimen processing and storage and quality control of samples. Arrangements have been put in place for kConFab laboratory staff to initially perform the RFK ASK Study related laboratory tasks.
Currently…
After successfully gaining human research ethics approval in Victoria, a submission has now been made to the NSW Population and Health Services Research Ethics Committee to cover both the Prince of Wales and Royal Prince Alfred Hospitals, which will be initially reviewed mid May. An application to the Princess Alexandra HREC has also been made for the Princess Alexandra Hospital and will be reviewed early May.
The RFK ASK database and associated server is currently being configured and will be housed at the Peter MacCallum Cancer Institute. The database has been customised for the RFK ASK Study and will have the capacity to cater for the considerable data management requirements of the project, bearing in mind the need for privacy and confidentiality of participant information. The system has the latest security features and will be networked so that RFK ASK Study staff at sites across Australia can access the database and upload information at any time. An online version of the participant questionnaire is also under construction. This will allow the Research Nurses to interview participants, complete the questionnaire and upload responses in real time.
In parallel with the HREC applications, submissions to each of the state cancer registries have been formulated. Thus far, applications to Victoria and NSW have been made and are awaiting review. Having access to the information held by these registries will allow the RFK ASK Study to verify cancer cases reported by study participants when speaking of their family medical histories, and thereby increase the integrity of the collected data. This will allow genetic patterns and heritable risks to be ascertained and predicted more certainly.
Next steps…
In early May, an application for human research ethics approval will be made to the UnitingCare Health HREC for initiation of the ASK Study at the Wesley Hospital in Brisbane.
Applications to other state cancer registries for data access to verify cancer pathology will be ongoing.
Set up and testing of the RFK ASK Study database at the various sites across Australia is planned for the coming weeks.
As HREC approvals are gained at each site and the study infrastructure is complete, site start up meetings and training will be held with key personnel. The site specific mechanisms for participant identification, recruitment and follow up will be fully refined. Database and study questionnaire training will take place. Convenient and regular communication opportunities and methods will be planned between site staff to ensure efficient running of the study.
At the Familial Aspects of Cancer: Research and Practice Conference to be held in Queensland in August, a training/feedback session for the ASK Study Research Nurses is planned. It is hoped that this will assist in optimising the ASK Study practise, identify any potential limiting factors for the study and generally promote a sense of support and communication amongst the ASK Study staff. It is anticipated that this will be an annual event.
