PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOspedale Santa Croce-Carle Cuneo

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

Treatment groups

390 Participants
are divided into 1 treatment group