Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Amy Lafont
-
asg55@cam.ac.uk


Ms Laura Stylianou
-
Ls2085@cam.ac.uk


Dr Amy Lafont
-
cuh.canrisk-clingen@nhs.net


Prof Marc Tischowitz
+44 (0)1223216446
Mdt33@medschl.cam.ac.uk


Dr Stephanie Archer
-
Saa71@medschl.cam.ac.uk


Study Location:

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Be Part of Research - Trial Details - CanRisk-ClinGen: A multi-site randomised controlled trial of multifactorial risk assessment in NHS clinical genetics services
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CanRisk-ClinGen: A multi-site randomised controlled trial of multifactorial risk assessment in NHS clinical genetics services

Recruiting

Open to: Female

Age: Mixed

Nottingham Cambridge Harrow Oxford Leeds Southampton London Birmingham Exeter London Cambridge

Medical Conditions

Risk of breast cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


To provide the best care to patients who are concerned about getting breast cancer in the future, healthcare professionals must assess that person’s future cancer risk. Traditionally, these risk assessments have been based on family history of cancer and, where available, the results from genetic tests that look for changes in genes linked to breast cancer. Whilst this method of assessing future risk of cancer has been used for a long time, from looking at information from hundreds of thousands of people who have developed (and not developed) cancer over many years, we now know that many other risk factors contribute to future risk. By combining information on these other risk factors alongside family history and the results of genetic testing, into a statistical model (called a multifactorial risk prediction model), a more accurate and personalised estimate of future risk is obtained.

The National Institute of Health and Care Excellence (NICE), now recommends that multifactorial risk prediction models are used to assess future cancer risk for breast cancer. To help clinicians conduct risk assessments in the clinical setting, a tool was developed called CanRisk. The CanRisk tool is available for use by all healthcare professionals. The CanRisk tool is being used within the NHS Clinical Genetics Services across the UK and varying amounts of risk factor information are being collected with people’s risk being assessed at different points during the patient pathway. This means that the risk assessment may not be 1) available at the most helpful time, 2) as accurate as it could be and 3) consistent across all genetics centres.

To address this, this trial aims to test a new care pathway where 1) the risk assessment is conducted at the earliest point after referral and 2) all patients receive genetic testing to provide them with as much risk factor information as possible. To assess if this pathway provides equivalent (or better) care, and to understand the impact it has on patients and staff, it needs to be compared to the existing care pathways that are in use across the UK. The best way to compare one pathway to another is to conduct a randomised controlled trial. Within a randomised controlled trial, half of the participants who are recruited are asked to have their care on the existing pathway (they are called the control group) and half are asked to have their care on the new care pathway (they are called the intervention group).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Aug 2024 14 Feb 2026

Anyone who wishes to take part in this trial must give their consent. After giving consent, participants will be randomly allocated to one of two groups (control or intervention). Each group has different tasks to complete during their participation.

For participants in the control group (existing pathway), there is one main task – completing a questionnaire as soon as they join the trial and then again at one, four and twelve months after they receive their risk category from the hospital. Some people in the control group will be asked to take part in an interview to better understand what their experience is of the existing pathway.

For participants in the intervention group (new care pathway), there are three core tasks – 1) completing four questionnaires (the same as the control group), 2) providing information about them and their family history of cancer via our MyCanRisk app, and 3) providing a saliva sample that can be used for genetic testing. Some people in the intervention group will be asked to take part in an interview to better understand what their experience is of the new care pathway.

The clinical progress of participants in both groups will be followed to see what happens to them in the longer term, beyond the scope of this trial, using databases such as the National Cancer Registration and Analysis Service (NCRAS), the Hospital Episodes Statistics (HES) and any another health record or registry that may be relevant or that might become available in the future. Participants will not need to do anything for this, other than completing the consent process.


Women aged 18-75 years old who have been referred to their local NHS Clinical Genetics Service via their GP or breast services team with a family history of breast cancer

You can take part if:



You may not be able to take part if:


1. Previous diagnosis and treatment for breast cancer2. Known pathogenic variant in BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1 within their family3. Previously undergone diagnostic genetic testing for BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD14. Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing5. Previously undergone risk-reducing surgery, has already participated in the CanRisk-GP study6. Known pathogenic variant in BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1, within their family7. Previously undergone diagnostic genetic testing for BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD18. Previously undergone multifactorial risk assessment (using CanRisk or another tool (e.g. IBIS Breast Cancer Risk Evaluation Tool)) incorporating risk factors, family history and genetic testing (panel +/- PRS)9. Previously undergone risk-reducing surgery (RRM/RRBSO)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nottingham University Hospitals NHS Trust
    Trust Headquarters Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge Biomedical Campus Hills Road
    Cambridge
    CB2 0QQ
  • Northwick Park Hospital
    Watford Road
    Harrow
    HA1 3UJ
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • St James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • St Georges Hospital
    Blackshaw Road Tooting
    London
    SW17 0QT
  • Birmingham Women's and Children's NHS Foundation Trust
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Royal Devon University Healthcare NHS Foundation Trust
    Royal Devon University NHS Ft Barrack Road
    Exeter
    EX2 5DW
  • St Thomas' Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • University of Cambridge
    Department of Medical Genetics Box 238, Lv6, Addenbrooke’s Hospital
    Cambridge
    CB2 0QQ

All women, regardless of participation in the study, will have their future risk of breast cancer assessed. For those who choose to participate in the study and are allocated the control group, the same care will be given as if they had not participated. As such, there is no direct benefit to the participant. For those allocated the intervention group, participants will receive a multifactorial risk assessment which is highly personalised and may be helpful in the future when making decisions about how to reduce or manage cancer risk.
There are no medical risks involved in taking part in this trial. There are no disadvantages expected for the control group participants. For those allocated to the intervention group, there is a possibility that it may take slightly longer than usual to get the risk assessment results than on the standard pathway. However, the study is designed in a way to reduce delay as much as possible and processes will be closely monitored. There is a small chance that a repeat saliva sample may be needed if it is not possible to extract enough DNA from the first sample. As the risk assessment in the intervention group requires genetic testing, the results may have an impact on participants and their families, should a change in a cancer-causing gene be found. Support will be offered throughout the risk assessment and testing process, and after the risk assessment has been made, through the local NHS Clinical Genetics Services.

Ms Laura Stylianou
-
Ls2085@cam.ac.uk


Dr Amy Lafont
-
cuh.canrisk-clingen@nhs.net


Dr Amy Lafont
-
asg55@cam.ac.uk


Prof Marc Tischowitz
+44 (0)1223216446
Mdt33@medschl.cam.ac.uk


Dr Stephanie Archer
-
Saa71@medschl.cam.ac.uk



The study is sponsored by Cambridge University Hospitals NHS Foundation Trust and funded by Cancer Research UK.



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Read full details for Trial ID: ISRCTN11466065

Or CPMS 56802

Last updated 04 November 2024

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