Breast CANcer - Risk Assessment in Young women
Research type
Research Study
Full title
A Case Control Study of women aged 30-39 to augment breast cancer risk prediction and assess acceptability and preference of a systematic risk prediction approach through primary care.
IRAS ID
309424
Contact name
Sacha Howell
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
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.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0268
Date of REC Opinion
17 Oct 2022
REC opinion
Further Information Favourable Opinion