1039 CytoMARK: development of a non-invasive in vitro diagnostics for endometrial cancer using cervical fluids

Introduction/Background Endometrial cancer (EC) is the fourth most common cancer in women, and its incidence is increasing. However, no screening methods are available to improve early diagnosis and diagnostic process initiates with women usually attending due to abnormal uterine bleeding (AUB). This triggers a multistep diagnostic process including office or hysteroscopic endometrial biopsies, which could be avoidable for 90–95% of women who have AUB and do not have EC. This study aims to develop a simple, non-invasive tool to accurately identify women at-risk of having EC using protein analysis in cervical fluids. Methodology Cervical samples from 264 women with abnormal vaginal bleeding were investigated using proteomic techniques. Those were divided in the following case-control retrospective clinical studies: a discovery phase of 59 samples (20 EC, 20 non-EC, 19 non-EC with cervical pathology) analysed by an untargeted mass spectrometry approach; a verification phase in 120 samples (12 EC and 108 non-EC); and a validation phase in 85 samples (35 EC and 50 non-EC). Analysis was performed using MaxQuant, Skyline, SPSS and R software. Cervical fluids were obtained using cytobrush sampling soaked in a saline solution. Results The discovery study determined 2,888 proteins contained in cervical fluids. Statistical analysis identified 75 significantly expressed proteins in EC compared to non-EC and were analysed in verification and validation phases using targeted proteomics. In the late breaking abstract submission, we will provide further information on the results derived from verification and validation phases, including independent and combined accuracy of the biomarkers for EC detection. Conclusion No conclusions to state, as we are going for the LATE BREAKING ABSTRACT submission. Disclosures Dr. Antonio Gil (A.G.M), Dr. Eva Colas (E.C.), Dr. Eva Coll de la Rubia (E.C.R.), Dr. Silvia Cabrera (S.C.), Dr. Elena Martínez García (E.M.G.) and Dr. Gunnar Dittmar (G.D.) are inventors on a pending patent protecting the results derived from this study. Dr. Antonio Gil (A.G.M) and Dr. Eva Colas (E.C.) are shareholders of MiMARK Diagnostics, which aims to license IP for developing innovative diagnostics in women health. The other authors declare that they have no competing interest.