DESCRIPTION OF STUDY
The purpose of this research project is to investigate how common oral HPV infection is in Australia and if oral HPV infection is linked to lifestyle or sexual behaviour. We are also interested in how the vaccines against HPV (Gardasil® of Cervarix®) affects oral HPV infection.
During the last decade, there has been a major increase in the number of mouth and throat cancers in younger non-smokers that are related to human papillomavirus (HPV). HPV is the major cause of cervical cancer and the cause of 5% of all human cancers worldwide. While other cancers related to smoking are decreasing, cancers of the mouth and throat are increasing in incidence and this is believed to be due to increasing oral HPV infections.
Despite the major increase of HPV-related mouth and throat cancers, remarkably little is known about oral HPV infection. It is not even known how common oral HPV infection is in the general population.
It is also important to map which HPV types exist in the mouth and throat for future prevention of mouth and throat cancers through vaccination.
WE ARE RECRUITING
Individuals aged 18 to 70 years who are currently living in Australia. Participants are not required to have a diagnosis or previous history of HPV to take part.
WHAT DOES THE SURVEY INVOLVE?
If you choose to participate, we will ask you to fill in a short online questionnaire.
We will then post a study pack containing a saliva collection kit and a consent form to ask permission to access your HPV vaccination data.
HOW LONG DOES IT TAKE?
Online questionnaire 5-7 min
Saliva sample and consent form 5-7 min
WHO IS CONDUCTING THE STUDY?
The study is being conducted by scientists at the QIMR Berghofer Medical Research Institute and is led by Associate Professor Annika Antonsson. The project has been approved by the Human Research Ethics Committee of the QIMR Berghofer Medical Research Institute.
CONTACT US
If you require any further general queries about the Oral Diversity Study, please see our contact details below:
Email: Oral.Diversity@qimrberghofer.edu.au
Call: 07 3845 3542
Write to: Locked Bag 2000, Royal Brisbane Hospital, Herston, QLD, 4029, AUSTRALIA
Recruitment status: CLOSED
QIMR-HREC approval reference: P3538
FAQ
We will ask you to:
- Consent to take part in the study (online)
- Complete a brief survey form (this takes 5-7 minutes and includes questions about your age, lifestyle and lifetime number of kissing and sexual partners; online)
- Donate a saliva sample that will be tested for the presence of HPV (in posted study pack)
- Consider to allow the study team to access your data about HPV vaccination in the Australian Immunisation Register (consent form in posted study pack).
Read the information sheet, consent form and answer the questions in the survey.
We will then post a study pack to you. The study pack contains a consent form to access data on your HPV vaccination, a saliva collection kit, biohazard bag to return the saliva sample in and a reply paid envelope.
Unfortunately, at this stage, we are unable to collect DNA samples from people living outside of Australia.
No, we will not give you the individual results from your samples.
We do not know yet what it means to test positive for an oral HPV infection, i.e. it is not known how common oral HPV infections are in Australia, how quickly an oral infection is cleared and whether a positive test result puts the individual at a higher risk of developing a cancer of the mouth or throat. Furthermore, there are currently no tests and no treatment for oral HPV infection.
Your participation in this study is completely voluntary and there will be no cost to you. If you do not want to take part in this study you do not have to. You should feel under no obligation to participate in this study.
You are under no obligation to continue with the research study. You may change your mind at any time about participating in the research. People withdraw from studies for various reasons and you do not need to provide a reason.
If you withdraw from the study, you will be able to choose whether the study will destroy or retain the information it has collected about you. You should only choose one of these options.
There will be no direct benefit to you from taking part in the study. However, findings from this study will help to understand how common oral HPV infection is and may benefit the general population in the future. There will be no cost to you and if you do not want to take part.
The only risk associated with your participation in this project is discomfort which you may experience as a result of the nature of the questions being asked of you in the questionnaire. However given our experience with previous studies, we expect that this is unlikely to occur and in the event that it does, that your discomfort would be minimal.
Study participation is strictly confidential. All patient information provided will be maintained in accordance with the Commonwealth Privacy Act (1988) and the National Health and Medical Research Council (NHMRC) Guidelines.
Any identifying information (your full name, address etc) will be stored separately from the samples and information you provide. Access to this identifying information is restricted to the members of the study team. Your identifying details will be kept separately in a password protected database on a secure QIMR Berghofer Server. Access to data for this study will be restricted to the few members of the study team at the QIMR Berghofer Medical Research Institute and will not be provided to any other sources.
Your questionnaires and samples will be stored securely in such a way that they cannot directly be identified as having come from you. They will be labelled with a unique number (studyID) so that they do not get confused with questionnaires, AIR data or samples from someone else.
PROVIDING A SALIVA SAMPLE
If you are having trouble producing a sample, please visualise squeezing a half-lemon.
Please note that any volume is useful, even with bubbles.
If you are still unable to produce a sample, take a teaspoon of water, vigorously swish it around in your mouth and add that to the tube.
Even if your saliva sample is discoloured in the tube (e.g., lipstick or food scraps or blood), there is still plenty of your DNA in the tube for us to extract and use. Please return it to us and if we need you to provide another sample we will be in contact.