PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors (PONDER)

November 26, 2025 updated by: Elena Olearo, Ospedale Santa Croce-Carle Cuneo

Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Signed informed consent

Exclusion Criteria:

  • Sarcomas, melanomas, mesotheliomas, hematologic malignancies
  • Advanced ovarian tumors
  • Fertility-sparing surgery with uterine preservation
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma
All patients will receive standard pre-, intra-, and postoperative care according to institutional guidelines. The peritonectomy procedure will not alter the choice of surgical access. Pelvic peritonectomy specimens will be analyzed as part of the final pathology report.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
Time Frame: from surgery up to at least 24 months of follow up after surgery
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
from surgery up to at least 24 months of follow up after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: from the date of surgery up to six months after surgery
Clavien-Dindo classification
from the date of surgery up to six months after surgery
Recurrence site
Time Frame: from the date of surgery up to at least 24 months of follow up
from the date of surgery up to at least 24 months of follow up
2-year progression free survival
Time Frame: 24 months after surgery
24 months after surgery
2-year overall survival
Time Frame: 24 months after surgery
24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Croce-Carle Cuneo

Investigators

  • Principal Investigator: Andrea Puppo, MD, Azienda Ospedaliera Santa Croce e Carle Cuneo
  • Study Director: Elena Olearo, MD, Azienda Ospedaliera Santa Croce e Carle Cuneo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

August 1, 2032

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CnGin20251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study data will be shared with investigators from other centers and results published according to national and international regulatory requirements

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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