PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

NCT07271914 | Not Yet Recruiting DMC

• 1 other identifier: CnGin20251
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ovarian cancer; early stage; ovarian tumor; peritoneal carcinosis; pathology assessment

Outcome Measures

Primary Outcomes (1)

• Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).

  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 Outcomes (4)

• Perioperative complications

  from the date of surgery up to six months after surgery

• Recurrence site

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

• 2-year progression free survival

  24 months after surgery

• 2-year overall survival

  24 months after surgery

Study Arms (1)

Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma

OTHER

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; Diagnostic Test: Histopathologic Analysis

Interventions

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

Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma

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.

Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Santa Croce-Carle Cuneo: lead

Study Sites (1)

Azienda Ospedaliera Santa Croce e Carle Cuneo

Cuneo, Italy

Location

Related Publications (1)

• van de Vorst REWM, Hoogendam JP, van der Aa MA, Witteveen PO, Zweemer RP, Gerestein CG. The attributive value of comprehensive surgical staging in clinically early-stage epithelial ovarian carcinoma: A systematic review and meta-analysis. Gynecol Oncol. 2021 Jun;161(3):876-883. doi: 10.1016/j.ygyno.2021.04.007. Epub 2021 Apr 10.

  PMID: 33849726 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Andrea Puppo, MD

  Azienda Ospedaliera Santa Croce e Carle Cuneo

  PRINCIPAL INVESTIGATOR

• Elena Olearo, MD

  Azienda Ospedaliera Santa Croce e Carle Cuneo

  STUDY DIRECTOR

Central Study Contacts

Andrea Puppo, MD

CONTACT

00390171642867; puppo.a@ospedale.cuneo.it

Elena Olearo, MD

CONTACT

00390171642369; eolearo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Intervention Model: Single Group Assignment

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): August 1, 2032
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)