A Study for the Future Design of an Early-Stage Breast Cancer Test
Research type
Research Study
Full title
A Non-Interventional, Proof of Concept Study to Collect Blood Samples from Patients with Stage 0-II Breast Cancer and from Healthy Participants to Measure Plasma Biomarkers for future development of an early-stage breast cancer detection test
IRAS ID
368310
Contact name
ANUJ CHAHAL
Contact email
Sponsor organisation
Faster Diagnostics Ltd
ISRCTN Number
Publication of this data is currently deferred.
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
Each year 56,900 new cases of breast cancer are detected, and approximately 11,200 women die annually in the UK, with future projections increasing to 11,500 annually.\nThis study will look at plasma to explore whether a set of research tests can identify patterns that are different in people who have breast cancer and people who do not. This is an early-stage study designed to see whether these tests can be developed into a test for early-stage breast cancer in the future. This study is not able to work out if the participants have breast cancer or not.\n\nIn this non-interventional study, enrolled subjects will provide one standard venous blood draw performed by a certified phlebotomist. Participants are expected to be consented and samples taken during a single visit to the study site. Sites will be Primary Care surgeries. \n40 participants will be enrolled into one of two age stratified groups: \n1.\t20 Participants aged 50-60 years: 10 breast cancer patients and 10 controls\n2.\t20 Participants aged 60-71 years: 10 breast cancer patients and\t10 controls\n\nThe study visit is expected to take approximately 45–60 minutes. \nParticipants will be asked to provide a blood sample, and test for HIV, Hepatitis B, and Hepatitis C and a urine pregnancy test if required\n
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0090
Date of REC Opinion
26 May 2026
REC opinion
Further Information Favourable Opinion