Bioendocar: In Search Of New Biomarkers For Diagnosis And Prognosis Of Endometrial Carcinoma.

Abstract Introduction/Background. Endometrial carcinoma (EC) is the most frequent gynecological malignancy in the developed world. Currently there are no valid non-invasive diagnostic or prognostic methods available and therefore, diagnosis and treatment of EC patients is guided by histopathological and surgical findings. The lack of non-invasive diagnostic and prognostic biomarkers of EC is addressed in the current clinical study titled “Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma” (BioEndoCar; NCT03553589). Methodology. Prospective observational case - control study. Patient recruitment takes place at six medical centers (University Medical Centre Ljubljana, Slovenia; Maastricht University, The Netherlands; Lublin Medical University, Poland; University Hospital Brno, Czech Republic; IRCCS Ospedale Policlinico San Martino, Genoa, Italy; University Medical Centre Maribor, Slovenia). Plasma samples from women with diagnosed EC and controls will be examined using non-targeted and targeted metabolomic (Helmholtz Zentrum München, Germany) and semi-quantitative immune-based proteomic (Sciomics GmbH, Heidelberg, Germany) approaches. Combined blood metabolome (>850 metabolites), proteome (>900 proteins), clinical and epidemiological data will be analyzed (University of Tartu, Estonia) in order to construct diagnostic/prognostic algorithms for early diagnosis of EC and to identify patients with low/high risk for cancer progression and recurrence. Results. BioEndoCar project has defined inclusion/exclusion criteria and a strict standard operating procedure for sample collection, processing and sample storage that is followed in all medical centers. Recently, the first milestone of the project was achieved: Since the beginning of the project (April 1st, 2018) more than 440 patients were recruited. Currently, proteomic analysis is ongoing: Using a selected cohort (100 patients), the discovery phase will allow to identify and select promising protein biomarker candidates, which will be validated on a separate cohort composed of 300 patients. Great effort was put into informing the lay and expert public about the importance of the translational studies in EC. BioEndoCar project has been presented at the ENITEC meeting and the ESGO congress. We have established an official website (https://bioendocar.eu/) and we are updating the community on the progress of the study using social media (https://twitter.com/car_endo). Conclusions. Within the project, we expect to find different metabolic and protein profiles in patients with early stages of EC as compared to controls and in patients with poor prognosis with high risk of disease progression and recurrence as compared to those with favorable prognosis. Citation Format: Eva Hafner, Špela Smrkolj, Andrea Romano, Henrica MJ Werner, Andrzej Semczuk, Aleksandra Kaminska, Aneta Adamiak-Godlewska, Dmytro Fishman, Jaak Vilo, Camille Lowy, Christoph Schröder, Janina Tokarz, Jerzy Adamski, Vít Weinberger, Markéta Bednaříková, Petra Vinklerova, Simone Ferrero, Fabio Barra, Iztok Takač, Jure Knez, Tea Lanišnik Rižner. BioEndoCar: in search of new Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 464.