CanRisk ClinGen V1
Research type
Research Study
Full title
Operationalising CanRisk in NHS clinical genetics services: A multi-site randomised controlled trial
IRAS ID
326139
Contact name
Marc Tischkowitz
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Across the UK, approximately 30,000 women are referred by their GP to clinical genetics services each year because they are worried about their family history of breast cancer. At the moment, a woman’s risk is assessed using their age and family history. Depending on the outcome of this risk assessment, some women will go on to have genetic testing to see if they carry a gene alteration that might help to explain the history of cancer in their family. Other women will be referred to other services to start medication or screening and some will be referred back to their GP.
As the risk assessment determines women’s future care, we need to make sure that the risk is as accurate as possible, and that it is conducted at the same time and in the same way, every time. New risk prediction models are now available that include a range of risk factors (e.g. lifestyle, hormonal and genetic) that can help to make the risk assessment more accurate and clinical tools, such as CanRisk, are recommended for use when assessing a woman’s risk. Despite CanRisk being available, it isn’t used to assess all women, and when it is used, the range of information added varies.To address this, we have developed a simple and standardised pathway that will ensure that the a risk assessment using the CanRisk tool is completed for each woman, at the same point in the pathway, and includes the same information. Within this study, we want to test whether the new pathway impacts on the risk assessment given to women, and how it changes their care and the decisions women make about managing their risk. We will also explore what impact the risk assessment has on women’s psychological health, and the financial impact on the NHS.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0194
Date of REC Opinion
25 Oct 2023
REC opinion
Further Information Favourable Opinion