A study to include assessment of breast cancer risk in breast cancer screening (BC-Predict)

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

This study includes looking at the risk of developing breast cancer as a part of the national breast screening programme.

This study is open to women having screening as part of the NHS Breast Screening Programme in:

the Greater Manchester area
East Cheshire
East Lancashire

More about this trial

The risk of getting breast cancer isn’t the same for every woman. You might have a high risk or you might have a low risk.

There is a benefit to knowing what your risk of breast cancer is. Knowing that it is above the normal risk (above average) or it is high means you might be able to take medication to reduce the risk. And depending on your age you might be able to have more frequent mammograms.

These measures might help reduce the number of breast cancers diagnosed and help find breast cancers at an earlier stage.

The study will find some people who are at higher than average risk of getting breast cancer. Those that are at higher than average risk will have the chance to speak to a health professional about their risk and their options.

The team want to find out if it is possible to make this risk assessment part of the breast screening programme.

The aims of this study are to find:

how many women are willing to take part
how many women take the opportunity to talk to the healthcare professional about their risk
how accurate the information about risk is
how many women take up their option to reduce their risk

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if you are having screening as part of the NHS Breast Screening Programme:

and this is your first appointment for screening at a centre in the Greater Manchester area
or you are 57 to 63 years old and are having breast screening at a centre in East Cheshire or East Lancashire

Who can’t take part

You cannot join this study if any of these apply. You:

were born male
have had breast cancer
have had both your breasts removed (bilateral mastectomy)
took part in the PROCAS-1 study

Trial design

The study team need 8,000 women to join the study.

For this study you fill in a questionnaire. The questions ask about things that can influence your risk of getting breast cancer. Some of the questions are:

whether members of your family have had breast cancer and certain other types of cancer
your age when you started having periods
whether you have children and what age you were when pregnant

Some other questions are about your lifestyle such as:

do you drink alcohol
do you exercise
do you smoke or have you smoked

The team uses the answers to work out what your risk of getting breast cancer might be.

The team will know when you are going for a breast screening appointment. Before then they’ll post you:

a letter of invitation to take part in the study
a patient information leaflet about the study containing the study’s website address
telephone number of the study team if you need further information or explanation

To take part in the study you fill in a consent form Open a glossary item online.

You can do this on your:

computer
laptop
mobile phone

After this you can access the questionnaire. You must complete the questionnaire within 6 weeks before your screening appointment.

You might need to find out certain information to complete the questionnaire. So you can start the questionnaire, stop it and then return later to complete it.

You can receive a paper version of the questionnaire. Contact the study team to do so.

The study team will look at the results of your screening mammogram if you had it within the 6 weeks. They will write to you about your risk if you had a normal mammogram. They will also write to your GP about the risk.

If you didn’t have the mammogram within the 6 weeks the team will write to about your risk but it might not be as accurate.

If you have a diagnosis of breast cancer the team won’t write to you straight away. They will write to you about a year later to find out if you want feedback from the study.

You can talk about your risk with a healthcare professional who specialises in family history. They will talk about your risk and what options are open to you. This could be medication to help prevent breast cancer developing if your risk is above average or high. Or they may offer you mammograms if you are at a high risk.

Hospital visits

There are no extra hospital visits if you join this study.

Side effects

There is a chance you might get upset when you find out what your risk of getting breast cancer is. You can talk to your doctor or a member of your healthcare team if you have any concerns.