Along with the main trial, we will be running some sub-studies. The TRANS-SUPREMO study is one of these sub-studies.
The SUPREMO trial is designed to help clinicians to predict which patients will benefit from a course of radiotherapy. As part of the TRANS-SUPREMO sub-study, we would like to use the tissue removed during your mastectomy to develop a test, which would help us predict who requires radiotherapy treatment therefore preventing us giving radiotherapy to patients unnecessarily.
As part of the TRANS-SUPREMO sub-study, we would like to use the tissue removed at the time of your mastectomy to look at ways of helping us predict who should have radiotherapy by developing a test so that in future we irradiate as few people as possible unnecessarily.
Many people will not have further problems from their cancer even if they do not have radiotherapy.
Normally we preserve and store some of the cancer from your mastectomy so that, if you have cancer in the future, this material can be compared with the new biopsies.
We would like to take some small pieces of this stored cancer to set up a 'tumour bank' from all the patients in the study. If you agree to take part in the TRANS-SUPREMO sub-study a tiny piece of your tissue will be stored in a central laboratory in Edinburgh. It will be used for future research to help understand more about breast cancer and radiotherapy treatments.
Because the samples are not identifiable, allowing the use of the small pieces of the stored cancer will not interfere with your diagnosis or treatment now or in the future.
At the end of the study we will look at the material on everybody in whom the cancer has come back and some in whom it hasn't. By doing this we hope to find a set of proteins that are more frequent (or less frequent) when the cancer comes back but don't change when the cancer does not recur. The presence or absence of these proteins will form the basis for our test.
We would also like to take a blood sample (two teaspoonfuls) at the start of the study so that we can do similar tests on blood proteins. Other scientists or doctors may want to use this material. An ethics committee will consider their requests before they are allowed to go ahead.
Your cancer tissue and blood samples will only be used for investigations of the cause and treatment of breast cancer, and none will be passed on to any third party who might make a profit from your material.
We may match the details and outcome of your cancer or its treatment to studies using the stored tissue from your cancer, however this does not involve giving your personal details to any other researcher. Your cancer will be stored in a way that ensures it would not be identifiable and no one would be informed about specific findings related to you.