About this trial
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
Eligibility criteria
Qualifiers
Age ≥ 18 years
FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
Complete preoperative work-up (ultrasound, CT scan, tumor markers)
Laparoscopic, robotic or open surgical approach
Disqualifiers
Sarcomas, melanomas, mesotheliomas, hematologic malignancies
Advanced ovarian tumors
Fertility-sparing surgery with uterine preservation
Inability to provide informed consent
Trial design
Treatments tested in this trial
- systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach
- Histopathologic Analysis