Anti-angiogenic agents, such as Bevacizumab, have demonstrated survival benefits in ovarian cancer, particularly in patients at high risk of disease progression. However, these therapies are costly, associated with potential side effects, and may negatively impact quality of life, benefiting only specific patient subgroups. Therefore, identifying reliable, predictive, and prognostic biomarkers that can be seamlessly integrated into clinical practice is essential to optimize patient selection. Circulating endothelial cells (CECs)-mature endothelial cells shed from vascular walls following blood vessel damage-represent a promising biomarker for monitoring vascular injury, treatment response, and disease recurrence. While flow cytometry offers a rapid, cost-effective, and standardized approach for CEC enumeration, methodological variability across laboratories has historically limited its clinical utility. To overcome this, this study utilizes a standardized flow cytometry protocol (developed by Beckton Dickinson and the SCENIC consortium) combining DNA staining with a dried, pre-titrated 5-antibody panel to ensure consistent and reproducible CEC quantification. Additionally, emerging evidence suggests that specific microRNA (miRNA) expression profiles in primary tumor tissue and plasma reflect vascular damage and response to anti-angiogenic therapy. This study aims to evaluate the predictive and prognostic role of CEC counts (at baseline and post-treatment) in ovarian cancer patients receiving standard chemotherapy with or without Bevacizumab. Furthermore, it seeks to explore the correlation between baseline CEC levels and the expression of selected miRNAs in plasma and primary tumors.
Study Type
OBSERVATIONAL
Enrollment
148
Optimization of CEC assessment in patients with ovarian cancer and description of baseline CECs
Description of baseline CECs with descriptive statistics
Time frame: 4 years
Evaluation of changes in CEC counts following therapy (with or without Bevacizumab) in patients with ovarian cancer
Fold change of CEC counts between different assessments: baseline, at the end of chemotherapy, at progression
Time frame: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Progression-Free Survival (PFS)
Difference in PFS between subgroups of patients will be evaluated with log-rank test
Time frame: 4 years
Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Overall Survival (OS)
Difference in OS between subgroups of patients will be evaluated with log-rank test
Time frame: 8 years
Evaluation of changes in selected microRNA (miR) level following therapy (with or without Bevacizumab) in patients with ovarian cancer
Fold change of selected microRNA level between different assessments: baseline, at the end of chemotherapy, at progression
Time frame: 4 years
Assessment of the prognostic role of changes in selected microRNA levels over time in patients with ovarian cancer in terms of PFS and OS
Difference in PFS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test
Time frame: 4 years
Assessment of the prognostic role of selected microRNA in patients with ovarian cancer in terms of PFS and OS
Difference in OS between subgroups of patients with different microRNA level will be evaluated with Kaplan-Meier method and log-rank test. OS will be defined as time from the beginning of second line platinum based therapy and death or end of follow-up whichever comes first
Time frame: 8 years
Correlation between CEC counts at diagnosis and expression of selected microRNA in serum and primary tumors
correlation between CEC baseline counts and selected microRNA level
Time frame: 4 years
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