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NCT Number: NCT07271914

PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

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

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Key information

Conditions

Early Stage Ovarian Tumors Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Peritoneal Carcinosis Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Histopathologic Analysis

Diagnostic Test

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Perioperative complications

    Time frame: from the date of surgery up to six months after surgery

    Clavien-Dindo classification

  2. Recurrence site

    Time frame: from the date of surgery up to at least 24 months of follow up

  3. 2-year progression free survival

    Time frame: 24 months after surgery

  4. 2-year overall survival

    Time frame: 24 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Puppo, MD

CONTACT

[email protected]

00390171642867

Elena Olearo, MD

CONTACT

[email protected]

00390171642369

Sponsors and collaborators

Lead sponsor

Ospedale Santa Croce-Carle Cuneo

Other

Registry information

Official study title

Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study

Acronym: PONDER

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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