PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors

NCT ID: NCT07271914

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2032-08-31

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

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

Conditions

Early Stage Ovarian Tumors; Peritoneal Carcinosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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

Intervention Type: 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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Santa Croce-Carle Cuneo

OTHER

Sponsor Role: lead

Responsible Party

Elena Olearo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Puppo, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Santa Croce e Carle Cuneo

Elena Olearo, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera Santa Croce e Carle Cuneo

Locations

Azienda Ospedaliera Santa Croce e Carle Cuneo

Cuneo, , Italy

Countries

Italy

Central Contacts

Andrea Puppo, MD

Role: CONTACT

puppo.a@ospedale.cuneo.it

00390171642867

Elena Olearo, MD

Role: CONTACT

eolearo@gmail.com

00390171642369

Facility Contacts

Silvia Violante, MD

Role: primary

violante.s@ospedale.cuneo.it

00390171641539

References

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.

Reference Type: RESULT

PMID: 33849726 (View on PubMed)

Other Identifiers

CnGin20251

Identifier Type: -

Identifier Source: org_study_id