The EMBED Study: Early Markers for Breast Cancer Detection
Research type
Research Study
Full title
A prospective cohort study in women at increased life-time risk of developing breast cancer to look for blood-markers that would enable an earlier diagnosis of the disease.
IRAS ID
268986
Contact name
Douglas Easton
Contact email
Sponsor organisation
Cambridge University Hospital NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
Women at high risk of developing breast cancer often undergo a double mastectomy. Detecting the disease at an earlier stage could be a major step forward to eliminate the need to have risky surgery.
There has been considerable interest recently in using blood-markers in the early detection of cancer. ctDNA (circulating tumour DNA) is released by cancer cells into the blood-stream and is now an important blood-marker in advanced disease. The aims of this study are two-fold: (i) to further develop and use sensitive state-of-the-art assays to detect small amounts of ctDNA in the blood with increased sensitivity and (ii) to measure ctDNA over time in women who develop breast cancer. Using these blood-markers it may be possible to detect breast cancer at a much earlier stage.
We aim to recruit two cohorts of women:
(i) Cohort 1: Approximately 2700 women with a strong family history of breast cancer. These women will be asked to provide annual blood samples and complete some questionnaires for up to 3 years initially or until they receive a clinical diagnosis of breast cancer. For women who develop cancer we will analyse the ctDNA in the blood samples collected at the time closest to diagnosis. We will also obtain mammogram images and tumour samples to guide a more sensitive analysis. Following this, we will analyse the blood samples collected at other time points to establish the earliest point at which ctDNA can be detected in the blood.
(ii) Cohort 2: We aim to recruit at least 100 women who have been recalled to the Breast Unit because of abnormalities seen on their recent mammogram (in Cambridge only). We will take blood samples from these women to refine and validate the ctDNA assays in readiness for use with cohort 1.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0052
Date of REC Opinion
14 Apr 2020
REC opinion
Further Information Favourable Opinion