A study looking at the role of genes, the immune system and diet in the outcome of breast cancer treatment (BeGIN study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

In this study researchers are looking into how the differences between people with breast cancer can affect how well breast cancer treatment works.

More about this trial

We know from research that several things can affect how well breast cancer treatment works. These include

your genes
genetic changes in the cancer
how your immune system responds to the cancer
your weight and diet

Previous research has looked at all these areas individually. In this study the researchers want to look into all these factors. They hope they can see which of these has the biggest effect on how well treatment works. This could then help doctors plan treatment so that people only have what they need.

The researchers will take samples of blood and cancer (a tissue sample). They need these samples from people who are just diagnosed with breast cancer and those who have recently had surgery.

Who can enter

You may be able to join this study if the following apply. You are going to Southampton General Hospital and

Have been diagnosed with breast cancer
Are aged 18 years or older

Trial design

This is an observational cohort study. A cohort is a group of people and cohort studies look at groups of people. The researchers hope up to 500 people will take part over 5 years.

The researchers will ask you to take part in the study during an appointment at the breast clinic at Southampton General Hospital.

At the appointment, before your surgery, they will also ask

you about what vaccines you have had and your medical history (or with your permission the doctors will check with your GP)
you to have extra blood tests on the day of your surgery
to measure your height, weight and body composition, this will be in the time before your surgery

They will also take a sample of your cancer when you have your surgery. Taking part in the study will not affect the operation you have.

For people who have already had surgery for breast cancer, they will ask

you about what vaccines you have had and your medical history (or with your permission the doctors will check with your GP)
you to have extra blood tests, you will have them at one of your follow up appointments
to measure your height, weight and body composition, they will do this at one of your follow up appointments

The researchers will use a sample of your cancer your surgeon took when you had your surgery. Samples are routinely stored at the hospital.

Everyone taking part will have extra blood tests as part of the study. This will be

when you finish having regular follow up with your breast cancer doctor (usually after 2 to 5 years)
if you need to come back for further tests or breast cancer treatment in the future

You have these tests during a routine appointment.

This study is a partnership between the University of Southampton and Breast Cancer Now (formerly Breast Cancer Campaign). The university will use your samples for this study and then share the samples with Breast Cancer Now’s tissue bank. This is a collection of breast cancer samples from people all over the UK. Currently these samples are being used to look into the role of genes and breast cancer treatment.

All of your information is kept confidential and when your samples are transferred to Breast Cancer Now all your personal details are removed.