Fair processing of Data
What the study is for
We are trying to find out more about the causes of breast, ovarian and prostate cancer in people with a family history of the disease. A small number of people have an increased risk of these cancers as a result of inheriting a mutation in specific genes, but we do not know what other genetic or lifestyle factors may be important. This study is trying to identify these other risk factors. This is a long-term study, which has and will continue to contribute to scientific papers. Papers using our data can be found here [EMBRACE], here [CIMBA] and here [IBCCS].
How we collect data
We work with a large number of genetic counsellors over the whole of the U.K. who will discuss the Embrace study with potential recruits during their appointment. The exact process of recruitment varies a little between different clinics, but eligible interested patients will be provided with a baseline questionnaire appropriate to their gender, a Patient information sheet that summaries the key points of the study and a consent form that must be signed and returned to us before we can enroll the patient.
As well as the baseline questionnaire we also request a blood sample. This is usually obtained by making an appointment with your GP, who we will contact for you in advance (with your permission) to ensure their willingness to do this. Most GPs request a small charge from us for this service. Once we receive the blood sample it will be stored at our laboratory for future use with an artificial unique id (your name and personal details are not known by the laboratory staff). The blood samples will have their DNA extracted for genotyping (a chemical based process for ‘reading’ your DNA) in large batches.
In addition to the questionnaire, data will also be sought from medical and pathology reports. These will include details of all cancer diagnoses, including staging and treatment, and screening history. We will write to the appropriate hospital to obtain the medical details:
- With cancers this will involve information on the exact type of tumour as there are distinctive subtypes and characteristics.
- For surgeries we require information on what type of operation was performed and the reason for it.
- With treatments we are interested in which drugs were used and for how long.
- Additionally we may request copies of certain mammograms and MRI scans.
We will also send some details to NHS Digital (See ‘How we use your provided personal details and health history’ section below) so that we can receive notification of any future cancer diagnoses or passing.
The Embrace data can be split into different subgroups, the key distinction is always whether the participant carries a genetic mutation in the BRCA1 and/or BRCA2 gene, or whether they are a family member of someone who does. We call these groups ‘carriers’ and ‘non-carriers’ respectively. Those who have been shown to be carriers through their clinical testing, and those whose carrier status is currently unknown*, will receive further questionnaires and requests for blood samples over time. This is generally 2, 5 and 10 years after your initial recruitment. Conversely the non-carriers will not receive follow up questionnaires or blood requests, we rely on information from NHS Digital only.
*This covers anyone who has been to a clinic (and has joined the Embrace study) but has not been tested at their clinic or has decided they would rather not know the result of the test.
How we use your provided personal details and health history
The information you provide on your health and lifestyle is known only to the Embrace study and will be used only for medical research. Your name and address are used by the study investigators, so that we can contact you personally.
In addition, identifiable data including your name, address, date of birth and NHS number are supplied by us to NHS Digital [https://www.digital.nhs.uk/article/219/What-is-NHS-Digital-] to enable Embrace to obtain data from your medical records, but we do not send them information on your health. We will receive details from the NHS Digital on a periodic basis regarding any cancer diagnoses that study participants may have had. NHS Digital will also provide us with information from the Office of National Statistics (ONS – https://www.ons.gov.uk/aboutus) about those who may have passed away since the start of our study, including date and cause of death, which also helps us avoid attempting to make further contact. The reasons for obtaining data from NHS digital and the ONS are to make sure that we have up to date and correct information and to ensure that the results of the study are as accurate as possible.
All data is handled and held under appropriate secure conditions by the study team. Your information undergoes pseudoanonymisation for all data analysis. This means your data is pooled with thousands of others and each person is only identified by an artificial identifier rather than by their personal details, such as their name. All publications and presentations are based on these large datasets and do not use individual records, instead they display results of our analyses using tables and graphs.
Withdrawing from the study
Participants are free to withdraw from the Embrace study at any time. If you would like to do so please tell us by writing, telephone or e-mail using the contact details below.
Centre for Cancer Genetic Epidemiology
Strangeways Research Laboratories
Cambridge CB1 8RN
Tel: 01223 740617
You don’t have to give a reason. Your decision will have no effect on your care or treatment in the future.
When withdrawing from the study, please also let us know if we can continue to use your data already provided, or if you would prefer for it to be destroyed. The following four examples show how you may wish to withdraw:
I wish to contribute again in future, but would rather not do so at present: This can occur when a questionnaire and/or a request for a blood sample arrives during a difficult time, for example whilst you are undergoing treatment. In this case we can skip a questionnaire and contact you again in future when you would be due for the next one. This would allow us to continue using the data we have collected so far, and to continue obtaining data from your medical records.
I no longer wish to be contacted: in this case we would no longer contact you, but you give us permission to keep and continue to use information (and any blood samples) you have already provided, and to continue to obtain and use information from NHS Digital, as before.
No further contact or access to your health records: we will not contact you again and we will not collect any more information through your health records; but you give us permission to keep and use the information (and any samples) already provided.
Complete withdrawal (no further use of data): in addition to no longer contacting you or obtaining information through medical records, we will destroy your information and of samples already provided. Your information may have been used in pseudoanonymised analysis datasets carried out in the past, but we will ensure that your information is not used in future.
If you have questions
You are very welcome to your contact at the genetic service, whose contact details will be listed on your patient information sheet, or the study coordinator Debra Frost (Embrace@srl.cam.ac.uk) at any time before or during the study.