CanRisk - GP STUDY (CPMS 56100, IRAS 326051)

UPDATED - 13/02/2024

Study Summary

This is a pragmatic study exploring the feasibility and acceptability of using the CanRisk tool in general practice to assess breast cancer risk amongst women. CanRisk is a prediction tool incorporating genetic, family history, lifestyle and hormonal risk factors to calculate the future risk of developing breast cancer, as well as the risk of carrying a pathogenic variant.

Women (40-49 years) will be invited to complete a breast cancer risk assessment. They will provide risk factor information via an online questionnaire (the MyCanRisk app) and then provide a saliva sample for polygenic testing. This study will not be testing for pathogenic variants such as BRCA1 and BRCA2.  

The study team will use that information and the CanRisk tool to generate a personalised risk estimate for each woman. Based on this and current NICE guidelines, participants will be categorised into one of three risk groups: 1. near population level risk, 2. near population level risk with additional family history risk factors, and 3. Moderate or high risk. All women will be sent a report of their risk alongside general breast health advice. Women at increased risk (e.g. risk groups 2 and 3) will be advised to make an appointment to discuss risk with their GP to clarify family history and be offered a referral to the regional clinical genetic service if appropriate. Once referred, women will then be managed in line with current practice. It is estimated that approximately 15-20% of women who take part in the study will be at increased risk. 

Inclusion Criteria

• Women aged 40-49 years, and registered with a participating general practice. 

• Capacity to consent.

• English speaker.

Exclusion Criteria

• Personal history of breast or ovarian cancer - known high risk gene mutation. 

• Previous diagnosis of metastatic cancer or entry on the palliative care register.

• Prior notification of dissent to research.

• Lack of capacity to consent. 

• Non-english speaker.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.