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Contact Information:

Prof Douglas Easton
dfe20@medschl.cam.ac.uk


Ms Joanna Mitchell
EMBED@medschl.cam.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - The EMBED Study: Early Markers for Breast Cancer Detection

The EMBED Study: Early Markers for Breast Cancer Detection

Completed

Open to: Female

Age: 30 Years - 69 Years

Medical Conditions

Malignant neoplasm of breast


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Jul 2020 31 Dec 2023

Observational

Observational type: Cohort study;



You can take part if:



You may not be able to take part if:


Women who are known carriers of the common pathogenic gene mutations (e.g. BRCA1 and BRCA2).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Macclesfield District General Hospital
    Victoria Road
    Macclesfield
    Cheshire
    SK10 3BL
  • Guy's Hospital
    Great Maze Pond
    London
    Greater London
    SE1 9RT
  • Castle Hill Hospital
    Castle Road
    Cottingham
    North Humberside
    HU16 5JQ
  • Royal Free Hospital
    Pond Street
    London
    Greater London
    NW3 2QG
  • St George's Hospital (tooting)
    Blackshaw Road
    London
    Greater London
    SW17 0QT
  • Barnet Hospital
    Wellhouse Lane
    Barnet
    Hertfordshire
    EN5 3DJ
  • The Queen Elizabeth Hospital
    Gayton Road
    King's Lynn
    Norfolk
    PE30 4ET
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    Leicestershire
    LE1 5WW
  • Charing Cross Hospital
    Fulham Palace Road
    London
    Greater London
    W6 8RF
  • Southmead Hospital
    Southmead Road
    westbury-on-trym
    Bristol
    Avon
    BS10 5NB
  • Chase Farm Hospital
    127 The Ridgeway
    Enfield
    Middlesex
    EN2 8JL
  • University Hospital Of North Tees
    Hardwick Road
    Stockton-on-tees
    Cleveland
    TS19 8PE

Prof Douglas Easton
dfe20@medschl.cam.ac.uk


Ms Joanna Mitchell
EMBED@medschl.cam.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by CANCER RESEARCH UK .




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for Trial ID: CPMS 45002

Last updated 16 April 2024

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