A study looking at the genetics of lobular carcinoma in situ (GLACIER)

Please note this trial is no longer recruiting patients.

This is a study to find genes that may increase the risk of lobular carcinoma in situ (LCIS) or a type of breast cancer called invasive lobular breast cancer. LCIS is not cancer but means that there are changes to some of the cells in the breast. Having LCIS increases your risk of getting breast cancer in the future.

In this study, the researchers will look at the genes of a large number of women who have been diagnosed with LCIS or invasive lobular breast cancer. They will find out more about their family history to see if any of their relatives have also had LCIS or breast cancer.

The aims of the study are

To identify genes that may cause or increase the risk of LCIS or invasive lobular breast cancer
To try and identify those women with LCIS who are more likely to develop breast cancer

Please note you won’t get any direct benefit from taking part in this study.

Recruitment

Start 11/06/2007

End 31/12/2011

Phase

Other

Who can enter

You can enter this trial if you

Have been diagnosed with LCIS or invasive lobular breast cancer (either recently or in the past)
Are female
Were 60 or younger when you were diagnosed with LCIS or invasive lobular breast cancer

Trial design

The study will recruit at least 2,000 women who have been diagnosed with LCIS or invasive lobular breast cancer.

A doctor who has been involved in your care will send you a letter explaining the study. If you agree to take part, you return the reply slip to the research team. A member of the research team will then contact you to give you more information about the study. They will send you

A letter
A questionnaire to fill in
A consent form for you to sign
A blood sampling kit

The questionnaire will ask questions about your health and the health of your family. By signing the consent form, you agree that the research team can look at your medical records.

You will give a small sample of blood. You may give this at the hospital or at your GP surgery. Whoever takes your blood will use the blood sampling kit provided by the researchers. They will then send the blood sample, along with the completed questionnaire and signed consent form, to the research team. They will give you a copy of the consent form to keep.

The researchers will look at the DNA from your blood to try and find genes that may increase the risk of developing LCIS or invasive lobular breast cancer. And they will try to identify women with LCIS who are more likely to develop breast cancer. If you have had surgery to remove breast tissue, the researchers may also get a sample of the tissue that was removed. They will do further genetic tests on this tissue sample.

If any of your close relatives have also had LCIS or invasive lobular breast cancer, the researchers may ask you to contact them about the study. If a relative is interested in taking part, the researchers will give you an information pack for them. The pack contains a letter explaining the study and a reply slip to send to the research team. If your relative returns the reply slip, one of the researchers will contact them directly to recruit them to the trial.

You may also ask a friend, or a relative by marriage, who hasn’t had LCIS or breast cancer to take part in the study. This is because the research team need to have some blood samples of a group of people who have not had LCIS or breast cancer that they can use as a comparison. This is known as a control group.

Hospital visits

Taking part in this study does not involve any extra hospital visits, apart from having the blood test.

Side effects

You may have some discomfort or bruising in the area where the blood sample is taken. There are no other side effects associated with taking part in this study.