A study comparing ways to assess breast cancer risk (CanRisk-ClinGen)
Cancer type:
Status:
Phase:
This study is looking at a pathway using the CanRisk assessment tool to assess breast cancer risk. The team are comparing this pathway to the usual pathway. A pathway describes the different steps you and your team need to take for you to get the care and treatment you need.
This study is open to women who have a 
of breast cancer and have been referred to an NHS Clinical Genetic Service.
More about this trial
The usual way for doctors and specialist nurses to assess breast cancer risk has been based on the person’s family history. They also use genetic testing where available.
We know that the risk of breast cancer is based on more factors than family history and genes. Other factors include:
- your height and weight
- whether you smoke tobacco or have smoked tobacco
- how much alcohol you drink
- whether you take an oral
contraceptive pill and for how long - whether you take
hormone replacement therapy (HRT) and for how long
The National Institute for Health and Social Care (NICE) recommend that healthcare teams consider a number of factors to assess your breast cancer risk.
MyCanRisk is a website that allows women to enter information about themselves and their family. This information is needed to perform an accurate assessment of the risk of breast cancer.
The CanRisk tool is an assessment tool that looks at the many factors of breast cancer risk. It is available for healthcare teams to use. We know that healthcare teams use the CanRisk tool at different times along the cancer risk pathway and in different ways. This means that the risk assessment might not be:
- available when it is most useful
- as accurate as possible
- the same across different genetic health services
In this study the team are looking at a pathway that uses the MyCanRisk website to collect information at the start of the process and collects spit (saliva) samples for genetic testing. This information is then entered into the CanRisk tool by the clinical genetics teams to find out what a person’s risk of breast cancer is.
The aim of this study is to find out:
- whether using MyCanRisk and the CanRisk tool is the same or better than the usual way
- how using the CanRisk pathway affects women having a risk assessment
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.
Who can take part
You may be able to join this study if all of the following apply. You:
- are female
- have a family history of breast cancer and have been referred to an NHS Clinical Genetics Service
- are between 18 and 75 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- have had a diagnosis of breast cancer and had treatment
- have a known gene variation such as BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1. Your doctor will know this.
- have had a genetic test for one of the above gene variations
- have used a risk assessment tool similar to CanRisk that looks at risk factors, family history and genetic testing, for example the IBIS Breast Cancer Risk Evaluation Tool
- have had surgery to reduce your risk of developing breast cancer. This is either surgery to remove your breasts or surgery to remove your fallopian tubes and ovaries.
- have taken part in the CanRisk GP study
Trial design
The study team need about 1,500 women to take part in this study.
You will receive a letter or an email inviting you to take part in the study. When you agree to take part, you fill in a questionnaire.
This is a randomised study. After completing the initial questionnaire, a computer puts you into 1 of 2 groups. Neither you nor the study team can choose which group you are in. The team will tell you which group you are in. The 2 groups are:
- the usual pathway
- the CanRisk pathway
Usual pathway
You see the doctor or nurse specialist at your local NHS Genetics Service for a risk assessment. You receive the results of the risk assessment in the post.
CanRisk pathway
The study team will send you a link to the MyCanRisk tool. You fill in the MyCanRisk tool online. It asks about yourself and your family. This information is used to work out your risk of developing breast cancer. It might take 30 minutes or more to answer the questions, depending on how many there are in your family.
You give a spit (saliva) sample. The study team will post you a kit to take the sample. The kit will contain instructions on how to do it and a stamped addressed envelope to return the sample. The team send the sample to a laboratory for genetic testing.
The team will receive the results of the testing. They will send them to the genetics clinic. When the genetics clinic has your results and the information that you put into MyCanRisk, they will put all of the information into the CanRisk assessment tool. They will post the results of the CanRisk assessment tool to you. If necessary, your healthcare team will refer you to another specialist service.
Questionnaires
Everyone in both groups fill in questionnaires after your risk assessment at:
- 1 month
- 4 months
- 1 year
The questions ask about:
- your general health and wellbeing
- how you found the testing experience
- any risk management you might consider. This is if you are at an increased risk of developing breast cancer.
Interviews
The team will ask some people from both groups to take part in an interview. This is to find out more about your experience of going through the pathway.
They will arrange the interview at a time and place convenient to you.
You don’t have to take part in the interview. You can still take part in the study.
Looking at your medical records
The study team would like your permission to look at your medical records. This is to find out about your health in the long term.
You don’t have to agree to this. You can still take part in the study.
Hospital visits
For women in both pathways, your doctor or nurse specialist may give you an appointment if you are at an increased risk of breast cancer. They then will refer you to specialist services if needed. If you are not at an increased risk of breast cancer, you may be given information about checking your breasts and where to go if you have any worries.
For women in the CanRisk pathway, if your spit (saliva) sample shows that you have a genetic , you will be asked to have a blood test to confirm this.
Side effects
It might take a bit longer for women in the CanRisk pathway to find out their breast cancer risk. The team have designed this study to shorten the delay as much as possible.
You might also need to give another spit (saliva) sample if there isn’t enough to do the testing.
We have information about the risks and causes of breast cancer.
Location
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
Dr Marc Tischkowitz
Supported by
Cancer Research UK
Cambridge University Hospitals NHS Foundation Trust
Population Research Committee
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
