Biomarker validation studies in UKCTOCS breast cancer samples
Research type
Research Study
Full title
Assessment of a multiplexed protein panel and a solvent interaction assay (SIA) in breast cancer serum samples from UKCTOCS.
IRAS ID
163293
Contact name
Usha Menon
Contact email
Sponsor organisation
UCL
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Breast cancer is one of the few cancers where screening methods are established and positive survival benefits established. However, although screening programmes are in place there are areas where improvements are needed. For example, it is difficult to distinguish tumour tissue in women with dense breasts, the costs of implementing mammography are relatively high in comparison to the benefits and over-diagnosis does occur. A simple, easily interpreted, low-cost blood test with high sensitivity and specificity could be used as a complement to current screens. It is proposed to asses two novel biomarker tests developed by OncoCyte and Cleveland Diagnostics which may enable earlier detection of breast cancer.
OncoCyte has discovered and optimised a novel breast cancer panel of proteins which has shown promising results in serum from breast cancer patients at time of diagnosis. Cleveland Diagnostics have developed a novel solvent interaction assay (SIA) which monitors changes in protein structures in response to cancers which has been shown to have superior performance to mammography.
The purpose of this study is to make an initial assessment of the performance of the OncoCyte panel and Cleveland Diagnostics assays in serum from 100 women who have developed breast cancer in the UKCTOCS trial and 100 healthy controls.
REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/1823
Date of REC Opinion
10 Oct 2014
REC opinion
Favourable Opinion