Abstract Epithelial ovarian cancer (EOC) has poor survival given no effective early detection strategies and non-specific early disease symptoms. We have formed a consortium with European and American partners to provide the necessary validation of a microRNA (miRNA) panel for earlier detection of EOC using serum samples and data from prospective cohorts, paired with clinical data and biospecimens. Our objectives are to validate a serologic miRNA panel that, together with CA125, would have sufficient diagnostic discrimination to be used as a tool that, complementary to imaging, would allow early identification and direction of patients with suspected malignancy to personalized gyn-oncological care. We will validate serum miRNA profiles as biomarkers for early detection in samples collected from cases ⇐3 years prior to EOC diagnosis and matched controls and characterize sources of variation in miRNA profiles and their impact on discrimination. Evaluate miRNA profiles in the clinical setting and the discrimination between EOC cases and women with (i) benign ovarian tumors in blood samples collected prior to diagnostic surgery and (ii) underlying comorbidities (including other cancer types). Further, we will evaluate serum miRNA profiles as predictors of recurrence and will compare tumor tissue and serum miRNA profiles. Develop and optimize protocols for data integration and methods for algorithm development. Direct in silico validation, including miRNA and CA125 levels, and clinical and epidemiologic data. Address Ethical, Legal and Social Aspects (ELSA), including activities in key stakeholder groups. Challenges in health data privacy and sharing, including for development of an artificial intelligence model, will be addressed, as will the definition of a “healthy” population with respect to miRNA profiles for EOC. The consortium was launched in 2023, with the first findings expected in 2024. Beyond the initial direct aims of the consortium, expanded aims on further promising markers are envisaged. Citation Format: Renée Turzanski Fortner, Hilde Langseth. MicroRNA as biomarkers in early detection and personalized treatment in ovarian cancer: Development of a personalized prevention consortium [abstract]. In: Proceedings of the AACR Special Conference on Ovarian Cancer; 2023 Oct 5-7; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_2):Abstract nr A050.
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