A study of people who have faulty breast cancer genes (EMBRACE)

This study will collect information about people who have inherited faulty breast cancer genes.

A small number of men and women have inherited faulty genes which means that they at an increased risk of developing certain cancers. Two of these genes are called BRCA1 and BRCA2. When someone has a fault in these genes they are more likely to develop cancers of the breast, ovary or prostate.

This study is called the EMBRACE study, which stands for Epide miological Study of Familial Breast C an cer. The researchers of this study aim to create a register of families who have a fault in these genes. The people taking part will be asked to fill in a questionnaire and to give a small sample of blood, which will be looked at in a laboratory. With this information they hope to find out

How many people go on to develop cancer
What other factors may play a part in the development of cancer
How the cancer risk may be reduced

The findings of this study will help doctors in the future to decide the best way to manage someone who has these faulty genes.

People will be asked to take part following counselling from a genetics clinic. Please note that you cannot volunteer to take part in this study.

Recruitment

Start 01/08/1998

End 30/09/2013

Phase

Other

Who can enter

You can enter this study if there is a faulty BRCA1 or BRCA2 gene in your family and

You have had genetic testing for BRCA1 or BRCA2 or there are plans to test you for these faulty genes in the future

You had genetic counselling and have been offered testing for these faulty genes, but have decided not to have the test

You may or may not have breast or ovarian cancer

You should also be

Well enough to take part in the study
At least 18 years of age

Trial design

This study is recruiting about 7500 women and a smaller number of men. All people taking part will be referred from their genetics clinic to the study team.

If you take part in this study you will be asked to complete a questionnaire. This will ask questions about your medical history and your lifestyle. You may be sent a further questionnaire about 2, 5 and 10 years after the first questionnaire. This will ask if there have been any changes since the last questionnaire.

You will be asked to give a small blood sample. If you do not want to give blood, you can still take part in the study. Your blood sample will be examined to understand more about your genetic make up. If you agree, you may also have a sample taken about 2, 5 and 10 years after the first sample.

The researchers may also ask your permission to look at your medical notes.

There is a smaller study going on as part of this one, called the Radiation History study. This part of the study has now finished recruiting people. The research team asked over 900 women to complete a further questionnaire about the medical examinations they have had in the past. Medical examinations, such as a CT scan expose you to low doses of radiation. One possible risk factor for breast cancer could be exposure to radiation. The researchers want to find out more about this in women with a family history of the disease.

Hospital visits

Your questionnaire will either be given to you in clinic or arrive in the post. You will be asked to return the questionnaire to clinic or by post.

You can visit your GP surgery, local hospital or your local genetics clinic to have a blood sample taken.

The information collected about you is confidential. Only the researchers have access to this information. The results of this study will be presented at medical meetings and published in various medical journals. Your personal details will not be included in these presentations or journals.

Side effects

This study does not involve a treatment and so there are no side effects associated with taking part. Your skin may bruise slightly after you give a blood sample.