Participant Information Sheet

Exposure to Fungus in the Home and Workplace and the Occurrence of Breast Cancer:
A Pilot Study

Invitation
You are invited to take part in a research project to find out whether a fungus/mould which is known to be a common environmental contaminant is present within cancerous breast tissue but absent from healthy breast tissue. The project will also aim to find out whether there is a possible association between environmental exposure to the fungus and its presence within breast cancer.

The study is being conducted by Mr Vincent Neil, the CEO of Mycotox Pty Ltd, Australia and Dr Jack Thrasher PhD, of Thrasher & Associates Medical/Legal Consultants, USA. The company Mycotox Pty Ltd performs commercial testing for indoor microbial contamination.

Before you decide whether or not you wish to participate in this study, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.

What is the purpose of this study?
Understanding the causes and risk factors associated with breast cancer is important for the future treatment and prevention of this disease. This study is examining a possible association between breast cancer and a fungus/mould which is a common environmental contaminant. This study will compare results obtained from the analysis of both the indoor environments and breast tissue samples of women with breast cancer and those free from breast cancer. In this way it will be possible to determine whether environmental exposure to the fungus, bacteria and associated toxins, has the potential to act as a risk factor for breast cancer.

How is this study being paid for?
The study is funded by Mycotox Pty Ltd, NSW.

Who can become involved in this study?
You will be eligible to take part in this study if you meet the following criteria:

• You are a woman aged 18 years or older.
• You are not pregnant.
• You have previously been diagnosed with breast cancer and have had a breast cancer biopsy taken within the last three years OR you have had a cosmetic breast procedure performed within the last three years which resulted in a tissue sample being collected and you have never received a diagnosis of breast cancer.
• You were residing at your current address for at least five years before you were either diagnosed with breast cancer or before you had cosmetic breast surgery.

What if I don’t want to take part in this study, or if I want to withdraw later?
Participation in this study is voluntary. It is completely up to you whether or not you participate. If you decide not to participate, there will be no negative consequences for you. If you do not take part in the study or decide to withdraw from the study, it will not affect your future treatment by staff of Mycotox Pty Ltd should you use any of the company’s services in the future.

If you wish to withdraw from the study once it has started, you can do so at any time without explanation and once again there will be no negative consequences for you. If you decide to withdraw you may request that data already collected be destroyed.

However, it may not be possible to return your samples to you or withdraw your data from the study results if these have already had your identifying details removed, or if the data has already been used in the publication of the study’s findings.

What does this study involve?
If you decide to participate, you will have to sign the Participant Consent Form.

You will be asked to provide the following information:

• Your age.
• The address of your home and your contact details.
• The address of your workplace and your employer’s contact details.
• Date of initial diagnosis with breast cancer and date tissue biopsy taken (for breast cancer patients) or date cosmetic surgery performed and date tissue sample taken.
• Location at which your tissue sample is stored.
• Length of time you have lived at your current home.
• Length of time you have worked at your current workplace.

You will be asked to allow representatives from Mycotox Pty Ltd to perform sample collection within your home. This sampling will occur on one occasion only and at a time that you agree to. Sampling will involve taking air and surface samples from within your home as well as taking samples from any subfloor void. This onsite testing will be carried out by Vincent Neil, from Mycotox Pty Ltd who is the Chief Investigator. This part of the study will involve between two and four hours of your time.

If you are currently working, you may also be asked to allow testing within your workplace. You will be asked to provide details of your employer so that the Investigator Vincent Neil can contact them and organise for sampling to take place. This sampling will occur on one occasion only and at a time you and your employer agree to. Sampling will involve both air and surface sampling and will be carried out by Vincent Neil from Mycotox Pty Ltd.

You will also be asked to assist in organising for Mycotox Pty Ltd to gain access, on one occasion only, to your stored breast tissue. You will do this by speaking to your medical practitioner and/or pathology service and by signing a release form if required by the pathology laboratory responsible for the storage of your tissue. In total this should take no more than an hour of your time.

Analysis of the samples collected during the study will be undertaken both within Australia and the USA. This study will be conducted over a period of three years. 

How much time will it take?
In total it is estimated that participation in this study will not exceed 9 hours of your time.

Risks
We do not foresee any risks if you decide to participate. However, participation in the study will involve some inconvenience to you personally.

You will be required to assist in arranging with your medical practitioner and/or pathology laboratory for Mycotox Pty Ltd to have access to your stored breast tissue sample.

A representative from Mycotox Pty Ltd will carry out sampling within your home and possibly your workplace. You will be required to be present when sampling is carried out at your home. You may also be required to assist in organising with your employer for testing to be carried out at your workplace. You should be aware that your personal information may be revealed to others if environmental testing is carried out within your workplace. Under these circumstances your personal information, regarding your having undergone a breast tissue biopsy for example, may be unavoidably revealed to some co-workers or staff.

Costs
Taking part in this study will be at no cost to you. You won’t be paid for taking part.

Benefits
Although there will be no immediate personal benefit to you and you will not be provided with your individual results your contribution may enable us to improve the current understanding of the causes and potential risk factors associated with breast cancer.

The information gained during this study may allow us to identify a novel risk factor for breast cancer. In the long-term the project has the potential to reduce the burden of this disease on the wider community.

Confidentiality
All the information collected in this study will be treated confidentially and will be stored securely within a safe and password protected computer at the Mycotox Pty Ltd premises. Only the Investigators Vincent Neil and Dr Jack Thrasher will have access to both participant names and the data collected for each participant. The test results for each participant will be identified with an individual identity number and participant names will not be used during laboratory and data analysis. Laboratory analyses for the fungus and some associated toxins will be carried out by Dr Dennis Hooper of Real Time Laboratories, Inc., USA, however all data provided to him will be identified using identity numbers only and participant names will not be used.

The study results may be published in peer reviewed scientific publications, presented at conferences and published on the Mycotox Pty Ltd website, but publications will not include any information identifying individual participants.

Information regarding participant identity will be kept for a minimum of 7 years after the publication of results, in order that any queries about the conduct of the study can be addressed. After this time this information which may identify the participants will be destroyed by the Investigator Vincent Neil. The data collected during the course of this study will be stored indefinitely in a de-identified form as part of a database to be used for potential future research.

What happens with the results?
We plan to publish the results in peer reviewed scientific publications and on the Mycotox Pty Ltd website and to present the results at conferences and other professional forums. Results may also be disclosed to the Family Planning NSW ethics committee for monitoring purposes.

In any publication, information will be provided in such a way that you cannot be identified. The overall or group results of the study will be provided to you, if you wish. You may indicate that you would like to receive a summary of the study’s findings on the consent form provided.

How can I get more information?
Please feel free to ask questions about anything you don’t understand, by firstly emailing Vincent Neil at ua.ten.knilretnuhobfsctd@1krowten.

Who should I contact if I have concerns about the conduct of this study?
This survey has been approved by the Family Planning Ethics Committee.  If you have any concerns about the ethical conduct of this research, you may email ua.gro.wsnpfobfsctd@scihte or call the Ethics Executive Officer on 02 8752 4386. Any issues you raise will be treated in confidence and investigated fully, and you will be informed about the outcome.