“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
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.
More about this trial
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.
Recent laboratory research has shown that other gene changes may also be involved in the development of certain types of cancer. So the researchers in this study will be looking for a number of different faulty genes.
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 different genes. The people taking part will be asked to fill in a questionnaire and to give samples 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.
Who can enter
You can enter this study if there is a faulty gene in your family and
- The faulty gene is known for increasing the risk of developing breast or ovarian cancer
- You have had genetic testing or there are plans to test you for these faulty genes in the future
You should also be
- Well enough to take part in the study
- At least 18 years of age
This study is recruiting about 11,000 women and 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 may be asked to give blood samples:
- when you join this study (baseline)
- every year
- 2, 5 and 10 years after the start of this study
Your blood samples will be examined to understand more about your genetic make up.
The researchers may also ask your permission to look at your medical notes.
Some women will also be asked to give a sample of cells from the surface of their cervix. You have the sample taken in the same way as if you were having a cervical screening test.
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.
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 the blood samples 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.
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.
How to join a clinical trial
Professor Douglas Easton
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Cambridge