What is the research attempting to find out?
The FORECEE Study is a unique research programme at UCL, investigating molecular (genetic and epigenetic) and bacterial/viral factors that may predict a woman’s risk of developing breast, ovarian, womb and cervical cancer (the 4Cs).
What happens at the Research Clinic?
At the BRCA PROTECT Research Clinic, a doctor will explain the aims of the study and you will have the opportunity to ask any questions you might have.
You will then be asked to sign a consent form and will be given a copy to keep. With your permission, we may contact your GP or other medical teams looking after you in order to acquire more information regarding your medical background.
You will also be asked to complete a questionnaire that will include questions about your medical, reproductive history and general health, history of cancer in the family and any symptoms that you may have experienced.
A nurse or midwife will take a cheek swab (one from the left and one from the right side of your mouth) and a blood sample.
In a private setting, a cervical smear will be obtained by a trained female research nurse or gynaecologist. This will be carried out in exactly the same way as smears done on the NHS national cervical screening programme. If this is your first smear, we will explain how the sample is obtained.
We need all three samples to conduct our research, and unfortunately cannot include anyone in the study who cannot provide all three samples.
What are the possible disadvantages of taking part?
As with all medical procedures, there are minor risks associated with donating biosamples, including bruising following the blood test and discomfort and bleeding/spotting following the cervical smear. Again we will be on hand to ensure that these symptoms are as minimal as possible.
What are the possible benefits of the study?
By participating, you will make an important contribution to the search for tests that can predict women’s cancer risk and hence ways in which the disease can be prevented. The study is not intended to provide a diagnosis to individual patients, though if the test proves successful we will inform any participant found to be at high risk, as long as they have indicated they would like to be informed. As a research volunteer, you may not derive any immediate benefits from taking part in this study. However, your participation will help us provide better ways of preventing women’s cancers and your contribution to this work is vital.
Will the cervical smear count as part of the National Cervical Screening Programme?
The sample we obtain is exactly the same as the one that is routinely obtained as part of the Cervical Screening Programme. However, this sample will only be used for research and so is additional to that, and it does not count as being part of the national screening programme.
Who are eligible to take part in the research?
Women between the ages of 18-75 years can take part in the study. Women with no known mutations, as well as women with known mutations are eligible. If you are a patient with current breast or gynaecological cancer, you can take part in the study, as long as you haven’t received any chemotherapy at any point, as this alters the results we obtain.
As a cervical smear is part of the set of biosamples we need to obtain, all participants in the study must be able to provide this sample. For clarity of the biological analysis, you should book a clinic appointment at a time in your menstrual cycle when you are unlikely to be bleeding (light spotting is usually not a contraindication to take part).
Who are not eligible to take part in the research?
Women who have undergone hysterectomy, who have had cancer in the past or received chemotherapy in the past, are not eligible for this study. Women who have had a smear in the last 3 months, or who cannot provide a smear sample, are also not eligible for taking part in the study.
Who will analyse the samples I provide?
The research involves national and international partners, several leading Universities as well as commercial companies. In order to ensure your anonymity, only coded data, with no personal identifiers, are used.
Do I have to stay enrolled in the study?
You are free to determine how long and for what purpose your samples will be used. You can also choose to withdraw from the study at any point. We would like your permission to store your samples after the initial study is completed, for a period of up to 25 years, though the study and collection period is only for 4 years. You may ask for your samples to be withdrawn from the study at any point.
What tests will be carried out on the samples I give for this study?
Donated samples will be tested for small biological changes that may help us predict future health factors, including the risk of cancer. Tests include genetic, epigenetic, DNA/RNA, protein-based, viral, bacterial and other biological techniques. Please ask the research team if you would like this to be explained further.
What happens if I’m found to be at risk of disease?
In the event that we find a possible gene mutation that we know may have a negative effect on your health, and you have indicated on the Consent Form that you would like to be informed about this, we will write to you and your GP. They will then arrange a meeting with a genetic counsellor, who will arrange for further tests and explain your options in terms of managing any potential risks. The results of the test will not be available to share with you immediately following the sample collection because of the way the samples are processed and tested.
If you are found to be at increased risk, we will aim to notify you within 48 months of collection. We do not provide diagnostic testing, that is, testing with the aim of establishing whether or not a mutation is present. Therefore, any risk mutations identified will need to be confirmed by an NHS laboratory. As our techniques are experimental at this stage, it is possible that some changes in your DNA, which may cause disease may not be identified using our current techniques. For this reason we cannot confirm the absence of a genetic mutation.
Will you be contacting me in the future?
We would like to contact you for information about your health after you join the study. It would of course be entirely up to you whether you give further information at any of these future contacts. We would also give your personal details to the appropriate regulatory bodies, which will inform us of any change in your circumstances.
What will happen to the results of the research study?
The results will be analysed by other medical scientists and published in the scientific press. If the results are significant, it is expected that they will be reported widely in the lay press. Preliminary results will probably be available within a two-year period. We aim to inform participants about the progress of our research, and will be available for questions at any time.
How will the samples and my personal information be used in the future?
A portion of the material extracted from your samples and obtained during the course of the study will be coded for identification, frozen and stored in special containers for future use. The samples and information will be securely stored for as long as needed in order to enable the research to be completed. It is possible that new tests or scientific techniques may be developed that have commercial applications. You would not benefit financially in such circumstances.
Will my taking part in this study be kept confidential?
Yes, your participation will be strictly confidential. Only the members of the research team involved in the current study will have access to your personal details. All the samples and tissue you give will be coded and all information collected about you during the course of the research will be treated in the strictest confidence. Personal information will never be made available to anyone outside the study and no identifiable information will be published.
What if there is a problem or what happens if something goes wrong?
If you find that during the course of your participation in the research you wish to complain, or have any concerns about any aspect of the way you have been approached or treated by members of staff then the National Health Service or UCL complaints mechanisms are available to you. Please ask your research doctor if you would like more information regarding any concerns you may have, and the complaints mechanisms open to you.
Who is organising and funding the research?
The study is being co-ordinated by the Department of Women’s Cancer at the Institute for Women’s Health, University College London, in collaboration with a number of European partners. The study is funded by a grant from the European Union (Horizon 2020, Grant Agreement Horizon2020 grant (EC 634570) to Prof Martin Widschwendter, UCL), supported by The Eve Appeal charity.