The MOBI-KIDS is an international multi-centric case-control study on risk factors for brain cancer in young people. Experts from 16 European and non-European countries are involved in the study.
Australian Arm - Research Team
- Professor Bruce Armstrong, School of Public Health, University of Sydney
- Dr Elizabeth Milne, Principal Research Fellow, Telethon Institute for Child Health Research, and Adjunct Professor, The University of Western Australia
- Dr Geza Benke
- Ms Rosa Schattner
- Ms Cassandra Wright [Melbourne]
- Ms Keren Fink [Sydney]
Australian arm funded by: NHMRC www.nhmrc.gov.au
Coordinating Country - Spain
- Professor Elisabeth Cardis
Centre for Research in Environmental Epidemiology (CREAL)
- Chelsea Eastman
Centre for Research in Environmental Epidemiology (CREAL)
- Vicent Pastor
Centre for Research in Environmental Epidemiology (CREAL)
This study is the Australian arm of an international multi-centre study involving 16 research groups that are investigating exposure to radiofrequency radiation from mobile phone use during childhood and adolescence and later onset of brain tumours in people between the ages of 10 and 24 years.
The overall objective of the current project is to assess the potential carcinogenic effects of childhood and adolescent exposure to radio frequency (RF) from mobile telephones on the central nervous system (CNS). In order to achieve the overall objective of the project, the study is focussing on the following specific aims:
- To conduct a multinational epidemiological case-control study of brain tumours diagnosed in young people in relation to electromagnetic fields (EMF) exposure from mobile telephones and other sources of RF in 9 countries under the European Union (EU) grant, and in 4 non-European countries (including Australia) which are not funded by the EU grant. (The Australian arm of the study is funded by the NHMRC.)
- To develop and validate improved indices of RF and extremely low frequency (ELF) exposure and assess related uncertainties for all of the subjects in the study.
- To analyse the relationship between risk of brain tumours and exposures to RF and ELF from mobile phones and other relevant and important sources of exposure in the general environment of young people.
The study is designed as a prospective multinational case-control study of brain tumours. The target study population are young people aged 10-24 years. In Australia the target regions for recruitment are the Melbourne, Sydney and Perth metropolitan regions. Recruitment has taken place over 2.5 years and it is expected that 178 cases and 356 controls will be recruited over this time period. Cases are young people with a confirmed diagnosis of a brain tumour and controls are young people recently hospitalised for an appendicectomy. Cases are recruited through neurosurgical departments of major hospitals and controls (patients with recent hospital admission for appendicectomy) are recruited through general surgical departments and medical records. There are two controls per case matched for age, sex and region of residency. Young people who met exclusion/inclusion criteria are asked to consent to allowing a researcher to interview them, have access to their medical records related to their brain tumour (cases only) and give researchers a saliva sample for DNA extraction using the Oragene collection kit.
The very rapid worldwide increase in mobile phone use in the last decade, with more than 1 billion users to date, has generated considerable community and research interest in the possible health effects of exposure to radio frequency (RF) fields. Of particular concern in recent years has been the growing use of mobile phones among adolescents and, more recently, children: as their developing neurologic system is thought to be more sensitive to the effects of RF and they are likely to have greater lifetime cumulative exposures to RF from mobile phones than those who started use later in life. Furthermore, the spatial distribution of RF energy absorption in the brain of children and adolescents may be different from that in adults. As a result, the World Health Organization (WHO) in its 2006 WHO Research Agenda for Radio Frequency Fields identified a high priority research need for a large-scale multinational study of brain cancer risk in relation to mobile phone use among children.
In Australia, mobile phone use is increasing, especially among children and young adults. This study is the Australian arm of an international multi-centre study that is investigating exposure to radiofrequency radiation from mobile phone use during childhood and adolescence and later onset of brain tumours in people between the ages of 10 and 24 years. There is considerable community concern and scientific interest about possible health effects from mobile phone exposure in young people and this multi-centre study will provide important information about such cancer risks.
Participants may not benefit directly from this research, but their participation is very important. It will help to increase understanding of the effects of the environment and genes in causing brain tumours and may help to prevent these tumours in the future.
Participants are asked their permission to agree to being interviewed by a study researcher for an hour. During the interview they are asked about their phone use and other things. This includes demographic information, previous residences and whether time was spent on a farm, mobile phone use including make and model of phones that have been used, number and duration of phone calls, SMSs, use of hands free devices, blue tooth, other wireless communication, cordless phone use, Wi-Fi use, exposure to other (not communication) sources of ELF and RF (i.e. electrical appliances, chargers, computers) exposure to medical radiation and questions regarding medical history.
Some saliva is collected from the participants. DNA (genetic code) is extracted from the saliva samples to test for changes that may be linked to brain tumours. We will NOT be doing tests on these samples for any other reason. Where participants have a brain tumour, consent is sought to allow access to their medical records. To accurately estimate recent use of mobile phones, permission is sought to have access to participants' mobile phone records for the previous year. Specifically, we seek grouped information about: number and duration of outgoing voice calls, number of SMS /MMS sent and total amounts of data download/uploaded.
Details of individual calls, SMSs or internet site addresses are not identifiable. Information is not obtained on content of calls, text messages, names or numbers of people participants have called or websites they have visited. Parents/guardians of participants are interviewed about family background including work history, family history of cancer, and the participant's school history. They are also asked some questions about before the participant was born and during their pregnancy.
The cases are all patients aged 10-24 years from the target population with a confirmed diagnosis of primary brain tumours, who are diagnosed during the study period (about two and a half years) and who give their informed consent (either themselves and/or their parent/guardian as applicable). Cases are histologically confirmed, either from surgery or biopsy material. Only when biopsy or surgery is not performed, cases are included on the basis of unequivocal imaging results. Exclusion criteria includes insufficient knowledge of English language and/or non-resident of the Sydney metropolitan area. A parent/Guardian of a case is selected at the same time as their child to be invited to participate in the study.
The young people are selected and recruited via the participating hospitals. Heads of Neurosurgical departments have been invited to participate in the study. A hospital liaison person was nominated to liaise with the patients and with the study research coordinator. Patients are identified through the weekly audit lists. Cases are histologically confirmed, either from the surgery or the biopsy material. Only when biopsy or surgery is not performed, cases are included on the basis of unequivocal imaging results. The nominated person [most likely a registrar] is the first to contact the patient to seek verbal and written consent to an approach from the study team. Once consent is received to approach the patient, the study team send out a patient pack to the patient/parent/guardian. The pack contains an explanatory statement and if agreed, consent form to read, complete and return. Where the patient is in the younger category a parent/guardian is asked to act on their behalf.
Where participants have a brain tumour they also consent to letting us get some details from their electronic medical records. We ask permission to obtain copies of pathology slides and reports, electronic radiology images and reports from the radiology PAC system (CT and MRI imaging and film) and surgical and discharge reports.
Controls are selected from among young people who are hospitalised for acute appendicitis, a disease that is common in all age ranges included in the study and not related to mobile phone use or SES (Socio Economic Status). This ensures that the controls are representative of the general population from which the cases arise. Two hospital controls are selected for each case. These are post operative patients hospitalised for an appendicectomy procedure (30572.00) or (30571.00) those who have a discharge diagnosis of appendicitis. Exclusion criteria includes a history of a brain tumour, insufficient knowledge of English, mental disability and/or non-resident of the Sydney metropolitan area.
Control selection runs in parallel to case ascertainment and is selected from the same population base as cases. The same population base means that controls are selected from the same metropolitan locality (Sydney) as the matching case. A Parent/Guardian of a control is selected at the same time as their child to be invited to participate in the study.
The young people are recruited through the general surgery departments of participating hospitals. Controls (those having had a recent hospital admission for an appendicectomy) are matched for age/sex/region (two controls per case) with a recruited case. The date of surgery for the matched controls must be +/- 3 months from the date of surgery of the case (or date of interview of the case if surgery was not performed).
The nominated registrar is the first to contact the patient (or if patient is aged 10 -17 their parent or guardian) to seek verbal consent to an approach from the study team. This is for the purpose of sending an information pack about the study. Once consent is received to approach the patient, the study team sends out a patient pack to the patient, parent or guardian. The pack contains an explanatory statement and a consent form to read, and if agreed, complete and return. Where the patient is in the younger category a parent/guardian is asked to act on their behalf.
Participation is voluntary
The study consent forms include the following phrase: "My participation is voluntary and ... I can withdraw from the study at any stage without being disadvantaged in any way and without any effect on the medical care I receive".
If a potential participant chooses not to participate in the study they are asked to complete a brief "non-respondents form" to be returned to the study coordinator in a reply-paid envelope or they may complete the form verbally by telephone. Participants may agree or refuse as they see fit.
Security of data
The de-identified data is electronically transferred to a secure common database and information kept in accordance with similar principles as our National Privacy Principles (NNP9). Data kept at Monash University is in locked filing cabinets and the database is password protected.
More information about the Mobi-Kids Study can be found at http://www.mbkds.com
The following Mobi-Kids Study contact points have been established at Monash:
Free call number: 1800-711 263
For further details about the Mobi-Kids Study:
Please contact the Project Officer, Ms Kristen Benke,
email@example.com or on +61 3 9903 0220