Evaluation of EARLY Biomarker Panel Stability for Ovarian Cancer Detection

The EARLY study focuses on evaluating the impact of various blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer. The goal is to potentially improve future ovarian cancer screening practices by understanding these factors. This study targets a real-world healthcare setting, aiming to recruit 1,500 participants through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. The importance of this study lies in its potential to enhance ovarian cancer screening methods, which could lead to earlier detection and improved patient care. Participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. The study will assess the feasibility of participant recruitment and blood sample collection, as well as the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage. Blood samples will be processed at different time intervals after collection to evaluate the effect of real-world sampling, logistics, and processing delays. The study will measure the robustness of the EV-based assay under real-world sampling conditions, the acceptability of the study by tracking the proportion of eligible participants who provide informed consent, and the feasibility of the study by determining the proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol.