Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Biomarkers, miR-484, Circulating Endothelial Cells, Bevacizumab
Brief 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.
Interventions
None listed
Sponsors
Centro di Riferimento Oncologico - Aviano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for Healthy Donors: * Healthy adults caucasian female * Non-smoker * Normal blood pressure values * Normal complete blood count (CBC) * Normal blood chemistry values Inclusion Criteria for Cancer Patients: * Caucasian * Patients with confirmed histological diagnosis of ovarian carcinoma (all histotypes) * Treatment-naive or with disease recurrence occurring more than 12 months after the start of therapy * Normal systolic and diastolic blood pressure values, no cardiovascular comorbidities * Written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimization of CEC assessment in patients with ovarian cancer and description of baseline CECs | 4 years | Description of baseline CECs with descriptive statistics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between CEC counts at diagnosis and expression of selected microRNA in serum and primary tumors | 4 years | correlation between CEC baseline counts and selected microRNA level |
| Evaluation of changes in CEC counts following therapy (with or without Bevacizumab) in patients with ovarian cancer | 4 years | Fold change of CEC counts between different assessments: baseline, at the end of chemotherapy, at progression |
| Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Progression-Free Survival (PFS) | 4 years | Difference in PFS between subgroups of patients will be evaluated with log-rank test |
| Assessment of the prognostic role of changes in CECs levels over time in patients with ovarian cancer in terms of Overall Survival (OS) | 8 years | Difference in OS between subgroups of patients will be evaluated with log-rank test |
| Evaluation of changes in selected microRNA (miR) level following therapy (with or without Bevacizumab) in patients with ovarian cancer | 4 years | Fold change of selected microRNA level between different assessments: baseline, at the end of chemotherapy, at progression |
| Assessment of the prognostic role of selected microRNA in patients with ovarian cancer in terms of PFS and OS | 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 |
| Assessment of the prognostic role of changes in selected microRNA levels over time in patients with ovarian cancer in terms of PFS and OS | 4 years | Difference in PFS between subgroups of patients will be evaluated with Kaplan-Meier method and log-rank test |
Contacts
PRINCIPAL_INVESTIGATORGustavo Baldassarre
Centro di Riferimento Oncologico di Aviano - IRCCS CRO
PRINCIPAL_INVESTIGATORFrancesca Rossi
Centro di Riferimento Oncologico di Aviano - IRCCS CRO
Outcome results
None listed