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.
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Status:
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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.
Hospital visits
There are no extra visits if you take part in this study. You have everything during routine appointments.
Side effects
There are no side effects associated with taking part in this study.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Mr. Ramsey Cutress
Supported by
Breast Cancer Now
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Southampton
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040