NCT Number: NCT07807683
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.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Healthy Donors:
Inclusion criteria
for Cancer Patients:
Exclusion criteria
Exclusion criteria
for Healthy Donors:
Time frame: 4 years
Description of baseline CECs with descriptive statistics
Time frame: 4 years
Fold change of CEC counts between different assessments: baseline, at the end of chemotherapy, at progression
Time frame: 4 years
Difference in PFS between subgroups of patients will be evaluated with log-rank test
Time frame: 8 years
Difference in OS between subgroups of patients will be evaluated with log-rank test
Time frame: 4 years
Fold change of selected microRNA level between different assessments: baseline, at the end of chemotherapy, at progression
Time frame: 4 years
Difference in PFS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test
Time frame: 8 years
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: 4 years
correlation between CEC baseline counts and selected microRNA level
Centro di Riferimento Oncologico - Aviano
Other
Flow Cytometric Evaluation of the Role of Circulating Endothelial Cells (CECs) as Potential Predictive/Prognostic Biomarkers in Ovarian Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05864144
Adenocarcinoma, Adnexal Diseases
Los Angeles, California, United States
View Trial DetailsNCT05348356
Adnexal Diseases, Endocrine Gland Neoplasms
Los Angeles, California, United States
View Trial DetailsNCT05979298
Adnexal Diseases, Endocrine Gland Neoplasms
Minsk, Belarus
View Trial DetailsNCT06339827
Adnexal Diseases, Cervical Cancer
Detroit, Michigan, United States
View Trial Details