THE MILLION WOMEN STUDY

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Summary

In this part of the Million Women Study, we are collecting blood samples so that we can include information from genetic and biochemical tests in our analyses. This is helping us to learn more about what makes someone susceptible to developing a disease.

What is the Disease Susceptibility Study?
In this part of the Million Women Study, we are collecting blood and saliva samples so that we can include information from genetic and biochemical tests in our analyses. This is helping us to learn more about what makes someone susceptible to developing a disease.
The Million Women Study offers a unique opportunity to study the effects of these risk factors in depth because it is so large (over 1.3million women are taking part) and because women have already given us such detailed information on the questionnaires about their use of medication and other lifestyle factors which may also affect disease risk.
For further information see the Detailed Investigation into Susceptibility of Disease on our Protocols page

Who is being asked to take part in the Disease Susceptibility Study?
Not everyone in the Million Women Study is being asked to give a blood or saliva sample. We ask some women who have reported having a specific illness, and others chosen at random. We have collected about 50,000 samples so far.

What does taking part involve?
We write first to everyone invited to take part in the Disease Susceptibility Study, asking if they might consider giving a blood or saliva sample. Some women may also be asked to complete an extra postal questionnaire at this stage.
For blood samples, once we know who is interested, we write to their GP asking for help in taking the sample. With women in the Million Women Study living throughout the UK, we cannot set up special clinics to take samples and we rely on the goodwill of GPs and their practice staff. If the GP does not object, we then send more information, a consent form and a blood-sampling kit to the woman. She can then decide whether or not to go ahead and arrange for the sample to be taken at her GP surgery. There are no repeat samples – women need to have blood taken once only.
For saliva samples, interested women are sent more information and a home saliva collection kit including instructions on how to collect your saliva and return the sample to us.

What happens to the samples?
The samples are sent back to us by the participant, and processed in our Oxford laboratory. Blood samples are separated into ‘buffy coat’ (containing white blood cells, which contain the DNA used for genetic tests) and plasma (the liquid part of the blood left after processing, which contains hormones and other chemicals). The blood and saliva samples are stored in freezers at -80 degrees Centigrade. With your consent samples will be stored for many years so that we can use them for a variety of tests, now and in the future. De-identified samples may be sent to specialist collaborating laboratories for genetic and biochemical tests in the UK or abroad.

Which tests will be done?
Most of the tests will be genetic tests, comparing genes from women with a particular disease with genes from women without the disease. We can then see whether some genes are associated with a specific disease. We will also be able to look at the joint effect of genes together with other risk factors; and to include some biochemical tests. Information from a woman’s blood or saliva sample will be put together with information from her questionnaires and with information we may request, with the woman’s consent, from GP or hospital medical records, or from other NHS records such as disease registries.
Genetic testing is a very rapidly developing field. It is not possible to say now exactly which tests it will be possible or useful, to do in a few years’ time. This is why we ask women to give their sample to the study as a gift, for us to test as we think most useful as the study progresses.

Are women told the results of the tests?
We do not send women or their doctors the results of the genetic or other tests. This is because the meaning of the test results will not be clear at this stage. Our tests will be research tests, which are not the same as those a doctor might do. The final results of the study will of course be published and will be available on the study website. We advise anyone concerned about their susceptibility to disease to contact their own doctor.

How are my sample and personal information kept safe?
As with every part of the Million Women Study we assure every woman taking part in the Disease Susceptibility Study that we will keep her personal information, and blood or saliva sample, absolutely confidential and will use it for medical research only. Samples are stored, transported and tested, identified only by a code number. This number is different from the Million Women Study ID number used to identify questionnaire information, and the link between the two is held securely. All analyses use data from which identifying information has been removed.
Blood and saliva samples, and the information obtained from them, may be shared with other approved researchers, both in the UK and abroad, under the terms of the The Million Women Study data access policy. All shared data and samples are de-identified.
The University of Oxford is the data controller for this study and processes research data as a task in the public interest. Data protection regulation provides you with control over your personal data and how it is used. Please see our Million Women Study Data Privacy Notice for further details.

Regulatory approval
The Disease Susceptibility Study has ethical approval from East of England Cambridge South (formerly Cambridgeshire 4) Research Ethics Committee: REC reference number 03/5/071.

For further information see the Detailed Investigation into Susceptibility of Disease on our Protocols page