“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
A study looking at improving the risk assessment of breast cancer in young women (BCAN-RAY)
This study is looking at the density of breast tissue in young women. The researchers want to find out if this has a strong influence on the risk of these women getting breast cancer.
It is open to young women who live in the Greater Manchester area and Cheshire.
More about this trial
Doctors use a mammogram to find out how dense the breast tissue is. Breasts are made up of lots of tiny glands that produce milk. This is glandular tissue and contains many more breast cells than other breast tissue such as fatty tissue. The more breast cells there are the denser the breast.
We know that the density of the breast tissue is a risk factor in developing breast cancer. The denser the tissue the stronger the risk is. This is especially so for women over the age of 40.
For younger women it isn’t known how strong a risk factor dense breast tissue is. In this study researchers are looking at the density of breast tissue in women between the ages of 30 and 39 years old.
They want to look at mammograms from women who have had breast cancer and women who haven’t had breast cancer.
As part of the study the team ask for spit (saliva) samples to look for
If you don’t have breast cancer having these gene changes doesn’t mean you will definitely develop breast cancer.
The aims of this study are to find out:
- how strong a risk factor dense breast tissue is for young women
- how to include this when working out their risk of breast cancer
- the most acceptable way to tell young women who don’t have breast cancer about their risk of getting breast cancer
Who can enter
The following bullet points are a summary of 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.
Only women from the Greater Manchester and Cheshire area can take part in this study. If your GP practice is part of the study you will get an invitation letter from them if you might be able to take part.
There are 2 groups in this study:
- Case group
- Control group
Who can take part
You may be able to join if have been diagnosed with breast cancer.
You may be able to join if don’t have breast cancer. You need to be willing to receive information about your risk of breast cancer.
All of the following also need to apply, you:
- were born female
- are between 30 and 39 years old
- are able to understand written English
There are sub studies in the main study. A member of the study team will talk to you about them if you might be able to join any of them.
Who can’t take part
You cannot join the Case group if you:
- have breast implants, had breast enlargement surgery or breast reduction surgery before you were diagnosed with breast cancer
- have had treatment for early breast cancer such as chemotherapy, hormone therapy, targeted therapy or trastuzumab
- were diagnosed with another cancer apart from
non melanoma skin cancerbefore you were diagnosed with breast cancer
- are pregnant
You cannot join the Control group if you:
- have had breast cancer
- have breast implants or had breast enlargement surgery
- have had both breasts removed (a double mastectomy)
- have been diagnosed with another cancer apart from
non melanoma skin cancer
- have any other medical condition or mental health problem that your doctor thinks could affect you taking part
- are pregnant, breastfeeding or have stopped breastfeeding less than 6 months ago
You cannot join if any of these apply. You:
- were born male
- have a known change in a gene such as
BRCA1or BRCA2that puts you at a moderate to high risk of developing breast cancer
- have a strong
family historyof breast cancer. You can ask your doctor about this.
There are 2 groups in this study.
The team need 250 women to join this group.
At one of your breast cancer clinic appointments a member of the team will talk to you about the study. If you want to take part they’ll ask you to complete a questionnaire. The questions ask about:
- whether there is a family member with a diagnosis of breast cancer or ovarian cancer
- your age when you started having periods
- whether you have been pregnant
- when you were diagnosed
- whether you used hormonal contraception such as the pill
- whether you have used hormone replacement therapy (HRT)
They take your height and weight. This is to work out your
You give a spit (saliva) sample. The team member will tell you how to do this. They will use this sample to look at your
The team will also look at your medical records and previous mammograms.
The team need 750 women to join this group.
You get a letter inviting you to take part in the study from your GP. The letter contains an information sheet about the study. After reading the information if you want to take part there is a web based application (app) you need to go on to. The team include the internet address for the app in the information.
When you are on the app you need to tick a box before proceeding. By doing this you give your consent for the study team to collect personal information. If you don’t want to give the team your personal information then you shouldn’t tick the box or go any further.
After ticking the box you:
- enter the unique identification number in the letter and your date of birth
- enter your email address. You also create a password in case you need to leave the app and come back later.
- answer a few questions. By answering these you give your consent to take part in the study.
- fill in a questionnaire about your risk of getting breast cancer. The team will estimate what your risk of getting breast cancer is from the answers you give. You may not be able to answer all the questions but the more information the team have the better they can assess your risk.
There is a phone number in the letter to contact the study team if you have any problems with the app or with answering any of the questions.
Family history of cancer
Some of the questions will ask whether any member of your family has or had cancer. The team use these answers to work out whether you might have a strong family history. Having a strong family history of breast cancer means you might be at a higher risk of developing breast cancer.
If you have a strong family history
You cannot continue in the study if you have a strong family history of cancer. The study team will ask your permission to send a letter to your GP. This will ask them to refer you to the family history clinic to further assess your risk of developing breast cancer.
If you don’t have a strong family history
You can continue in the study if you don’t have a strong family history of cancer. The team will make an appointment to see you.
You fill in an online questionnaire before the appointment. The questions ask about your:
- health and wellbeing
- knowledge, understanding and awareness of breast cancer risk
The team ask whether they can interview you about taking part in the study. This will be at a time and place convenient to you. You don’t have to agree to do this. You can still take part in the main study.
Seeing the study team
Before going to the appointment the team will ask you to give a spit (saliva) sample. You are sent the tube and instructions on how to do the sample in the post. You take the sample with you when you go to the appointment.
The team ask you some questions. You have a low dose mammogram.
They ask if you would like to take part in the cervical self sampling study. For this you take a sample from the
After the appointment
The team analyse your sample and mammogram to work out your breast cancer risk. You receive a letter based on whether your risk is average or is above average.
If your risk is about average the letter is about healthy living and breast awareness.
Above average risk
If your risk is above average in the letter the team will ask if you’d like an appointment at the Breast Cancer Family History Risk and Prevention Clinic at The Nightingale Centre, Manchester. This is to review your risk in more detail and to discuss any breast cancer prevention and screening that you may be suitable for you. This appointment is not a part of the study itself but part of NHS care. So they will need your permission to ask your GP to arrange this.
You fill in questionnaires 6 weeks and 24 weeks after receiving the letter about your risk from the study team. One is about your:
- health and wellbeing
- knowledge, understanding and awareness of breast cancer risk
You are also asked about:
- the risk information you received and how satisfied you were with it
- your decision to take part in the study
The team sends out the link by email or mail for you to access these questionnaires. They will send a prompting email or letter if you haven’t completed them within 2 weeks.
For the Case group there are no extra hospital visits.
For the Control group there is 1 hospital visit.
It might be upsetting to find out you have a gene change (mutation) that gives you a high risk of getting breast cancer. A member of the study team will talk to you about your risk and how it might affect you and your family.
Control group – low dose mammogram
A mammogram uses radiation and this might increase your risk of getting cancer. The mammogram you have uses a low dose of radiation and the risk of it causing cancer is very small. The amount of radiation you get is about the same as 4 to 8 days of radiation that occurs naturally (background radiation) such as sunlight.
A low dose mammogram won’t pick up cancer in your breast. It is important to see your doctor if you think you might have breast cancer.
How to join a clinical trial
Dr Sacha Howell
Manchester University Hospital NHS Foundation Trust
CRUK International Alliance for Cancer Early Detection (ACED)
The Christie Charity