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A Translational Study to Explore and Overcome Metabolic-driven Resistance Mechanisms to Standard Chemotherapy in High-grade Ovarian Cancer
This translational study, titled "A translational study to explore and overcome metabolic-driven resistance mechanisms to standard chemotherapy in high-grade ovarian cancer," is designed as a prospective, monocentric, observational cohort study utilizing biological material. The primary objective of this research is to evaluate the functional capacity of the U-Cup bioreactor to predict the clinical response to standard chemotherapy in patient-derived high-grade ovarian cancer tissues maintained in perfusion culture. As a secondary objective, the study seeks to develop a high-throughput platform for the personalized assessment of therapeutic responses. This platform will specifically focus on ovarian cancer cases that demonstrate resistance to standard chemotherapy, exploring their sensitivity to alternative metabolic-driven therapies. The study population consists of women diagnosed with high-grade serous ovarian carcinoma who have not previously undergone chemotherapy. These patients are candidates for surgical intervention at the UOC Ginecologia Oncologica De Iaco - IRCCS AOUBO. Eligibility for the study is strictly defined by specific inclusion and exclusion criteria to ensure a homogeneous and clinically relevant cohort. Inclusion requires patients to be 25 years of age or older, provide informed consent, and have a confirmed histological or surgical diagnosis of high-grade serous ovarian cancer. Furthermore, eligible participants must not have undergone prior surgical treatment for this malignancy and must have sufficient primary or metastatic tumor tissue available for sampling. Conversely, the study excludes patients presenting with significant comorbidities or those affected by other concurrent malignancies. Over a planned duration of 36 months, the study aims to enroll a total of 120 patients. For all parameters measured, including drug response tests related to the secondary objective, data will first undergo the Shapiro-Wilk test to assess the normality
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