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PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

NCT07271914 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2025-12-09

No results posted yet for this study

Summary

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

Conditions

  • Early Stage Ovarian Tumors
  • Peritoneal Carcinosis

Interventions

PROCEDURE

systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach

Surgical Procedure: Initial step: Exclude upper abdominal disease through inspection and guideline-based biopsies. Pelvic peritoneal resection: En bloc or segmental removal of predefined pelvic peritoneal regions according to dissection of retroperitoneal spaces with a nerve-sparing technique.

DIAGNOSTIC_TEST

Histopathologic Analysis

Fixation: 10% neutral-buffered formalin for 6-48 hours. Processing: Paraffin eembedding and complete sampling for histology. Staining: H\&E and immunohistochemistry (MOC-31, BER-EP4) to identify epithelial tumor cells. Reporting: Checklist for peritoneal disease

Sponsors & Collaborators

  • Ospedale Santa Croce-Carle Cuneo

    lead OTHER

Principal Investigators

  • Andrea Puppo, MD · Azienda Ospedaliera Santa Croce e Carle Cuneo

  • Elena Olearo, MD · Azienda Ospedaliera Santa Croce e Carle Cuneo

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2030-02-28
Completion
2032-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271914 on ClinicalTrials.gov