“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study looking at breast cancer risk during screening (PROCAS)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is collecting information linked to breast cancer risk from women taking part in the NHS breast screening programme in Greater Manchester.
If you are a woman aged between 50 and 70, and registered with a GP in the UK, you will be invited to have breast screening every 3 years. Screening can pick up cancer in the early stages. So if the mammogram showed that you had breast cancer, your breast cancer treatment should be more successful, as you would have it sooner.
The chance of getting breast cancer is not the same for all women. Some have a higher risk and some have a much lower risk. But at the moment doctors can’t tell who has a higher or lower risk.
Researchers in this study want to work out each woman’s risk. They will study mammograms, DNA from spit (saliva) samples, and results of a questionnaire that asks you about possible risk factors for breast cancer.
They hope to be able to accurately work out each woman’s risk of breast cancer. They will also make sure that any woman found to be at high risk of getting breast cancer is given advice on how to reduce their risk. And, if appropriate, offered screening more often, and closer monitoring. The aims of this study are to see if it is possible to
- Accurately predict breast cancer risk
- Include these processes as standard within the screening programme
The long term aim of this study is to work towards making it possible for women to be screened as often as they need to be, based on their personal risk.
Who can enter
You can enter this study if
- You have had your first mammogram in the past 3 months as part of the NHS Breast Screening Programme in the Greater Manchester area
- You are able to come for 2 screening appointments 3 years apart
You cannot enter this study if you have already had breast cancer.
This study will recruit about 60,000 women.
Before you have your screening mammogram, you will fill out a questionnaire. The questionnaire will ask you about things that could affect your risk of breast cancer, for example about your lifestyle and family history of cancer.
Two specialists will look at your mammogram in the usual way. A researcher will also look at how dense your breast tissue is on the mammogram. And use computer programmes to estimate the amount of dense tissue in your breasts. This will give the study team an idea of your breast cancer risk.
The team would also like to collect a sample of spit (saliva) from a small number of women taking part. If they ask and you agree, they will study DNA in your spit and look for any gene changes you may have. Having this gene test will not affect any insurance policy you or your relatives may have. You do not have to give a spit sample if you don’t want to. You can still take part in the rest of the study.
The team will use your mammogram and questionnaire information to work out your risk of breast cancer. Because it is using limited information, and may change once they have all the results at the end of the study, they call this the initial risk calculation. But if these first results show that you are at high risk of developing breast cancer, they will ask if you would like to discuss your risk. You will either meet with experts at University Hospital South Manchester, or talk to them over the phone. The team will also ask some women from the other risk groups if they would like to discuss their risk with experts. So you will not know which risk group you belong to before this meeting.
When you come back for your next mammogram in 3 years time, the team will also study the results from this.
Once they have all your information, the team will work out your likely breast cancer risk. They will ask if you would like to know your risk at the very end of the study. If so, they will write to you. They will ask everyone from the high risk group, and some women from the other risk groups if they would like to discuss their risk with experts at University Hospital South Manchester, either in person, or over the phone. You will not know your risk before this meeting. But the team expect that fewer than 1 woman out of every 100 (1%) will be at high risk. If you are at average, or below average risk and you are not asked to come to the hospital, you will find out your risk in this letter. You will also have written information on ways to reduce risk.
Everyone will also have the chance to discuss their results further either with the research team, or a helpline, if they wish.
You will not make any extra hospital visits to take part in this study.
If the team ask you to discuss your results, you can either visit University Hospital South Manchester to do this, or talk to them on the phone.
You will not have any side effects as a result of taking part in this study.
How to join a clinical trial
Professor Gareth Evans
Greater Manchester Comprehensive Local Research Network
NIHR Clinical Research Network: Cancer
The Genesis Breast Cancer Prevention Appeal
University Hospital of South Manchester (UHSM)
University of Manchester