Study of the Role of the Tumor Microenvironment in Ovarian Cancer

Background Proved the importance of microenviroment in the onset and progression of ovarian cancer, a detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies.

Primary Objective The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy.

Study Hypothesis To generate of ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and/or microbial-derived molecules).

Trial Design Patients with primary diagnosis of epithelial ovarian cancer (EOC) (stage III and IV according to FIGO) referred to the Obstetrics-Gynecology Department of ASUFC for surgical removal will be selected. It is expected that organoids will be cultured from 50 patients over the course of 3 years, obtained by removed tissue from which pathologist will collect a fragment of tumor tissue and one from adjacent normal tissue (as a healthy control). From tumor tissue they will extract three different fragments: one for the identification of cells composing the Tumor Microenvironment (TME) (through single-cell analysis), one for microbiome analysis, and one for organoid generation to be conducted at the laboratories of the Department of Medical Area.

Inclusion/Exclusion Criteria Patients with a diagnosis of EOC will be considered eligible if they meet these criteria: Age: 18 years - 80 years, serous ovarian carcinoma and FIGO Stage III/IV EOC. They will be excluded in case of ongoing or suspended immunosuppressive therapy within the last 6 months, congenital or acquired immunodeficiency, immunosuppressive state, administration of chemotherapy for another neoplasm in the past 12 months, non-epithelial ovarian tumors, patients not undergoing surgical intervention, BMI higher than 30, absence of Informed Consent.