BCAL’s previous studies showed that the BCAL lipid signature assessed initially from plasma extracellular vesicles, and in the latest study directly from plasma could potentially effectively distinguish breast cancer cases from negative and positive controls (healthy and benign respectively). We are undertaking this study to confirm test performance across different racial and ethnically diverse populations. We are also evaluating the feasibility for having samples collected, processed, stored in India following established SOPs and transported to BCAL’s R&D facility in Australia for testing and analysis. The pilot is to ensure specimen integrity is upheld as a lead into larger-scale clinical validation studies.

We hypothesise that the BCAL breast cancer lipid signature accuracy (sensitivity and specificity) in detecting breast cancer from fasted plasma in AFAB women from India performs as expected and there is minimal to no impact on specimen integrity, should samples be tested and analysed from Australia.  

This study is a multi-center, prospective cohort study involving a single-point collection of whole blood specimens by venepuncture with associated data, under informed consent for testing and analysis at BCAL’s R&D facility in Sydney, Australia.

PRIMARY OBJECTIVES

·         To determine the accuracy (specificity and sensitivity) of the BCAL breast cancer lipid biomarker signature for the detection of breast cancer in women from India, >30 years of age, with and without breast cancer.

SECONDARY OBJECTIVES

·         To assess biospecimen integrity following collection, processing, and temporary storage and transport from India to Australia for lipidomic testing.