Status: Open
Specialty: Breast
Date Opened: 11/07/2025
Planned Close Date:
Sponsor: Manchester University NHS Foundation Trust
Principal Investigator: Dr Sarah Moon
Study Title: Breast CANcer - Risk Assessment in Young women
Breast cancer (BC) is the most common cause of death in young women. Risk factors such as age at first pregnancy, mammographic density (MD) and genetic analyses can be used to identify older women more likely to develop breast cancer. However, these tools have not been adequately tested in young women without a BC family history. In this study we plan to refine these methods in a diverse population of women aged 30-39. We will recruit 250 women with BC from surgical/oncology clinics (cases) and 750 women without BC (controls) from GP practices serving ethnically and economically diverse populations across Manchester. All 1,000 women will complete a risk questionnaire and a saliva sample to assess genetic risk. The MD from the diagnostic mammogram for cases will be compared with automated low dose risk assessment mammogram (ALDRAM) for controls. This will allow personalised risk assessment in this age group for the first time. The risk of breast cancer will be fed back to the controls through a web based application and the acceptability and likely uptake of the approach will be assessed through questionnaires and interviews. We will also investigate a new method for BC risk assessment that we have developed using cervical self-sampling. Changes in the cervical DNA will be examined to determine whether this assessment can help to determine who will develop BC in the future. Overall we will have improved risk prediction models and defined whether this approach through primary care is acceptable to young women.
Main study
Cases and Controls
• Born biologically female
• Aged 30-39 years when diagnosed with breast cancer
• Able to provide informed consent
Exclusion Criteria
Main study
Cases
• Born biologically male
• Known germline Pathological Variant in a moderate or high risk BC gene
• Strong family history of breast cancer defined as:
o First degree relative diagnosed under the age of 60
o Two or more first or second degree relatives diagnosed with breast cancer at any age
• Breast implants or breast augmentation surgery at the time of breast cancer diagnosis
• Inability to understand written English
Controls
• Born biologically male
• Breast implants or breast augmentation surgery
• Any prior malignancy
• Bilateral risk reducing mastectomies
• Under follow up with breast cancer Family History or genetics clinic
• Strong family history of breast cancer defined as:
o First degree relative diagnosed under the age of 60
o Two or more first or second degree relatives diagnosed with breast cancer at any age
• Known germline PV in a moderate to high risk BC gene
• Inability to understand written English
• In the opinion of their GP any condition that would make breast cancer risk assessment inappropriate such as a severe psychiatric or physical illness.
Research Nurse: Hilary Thatcher
Administrator: research.oncology@mbht.nhs.uk
Link to EDGE