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NCT07807683

Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer

Sponsor: Centro di Riferimento Oncologico - Aviano

View on ClinicalTrials.gov

Summary

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.

Official title: Flow Cytometric Evaluation of the Role of Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

148

Start Date

2014-01-15

Completion Date

2024-12-31

Last Updated

2026-09-08

Healthy Volunteers

Yes

Conditions