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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative complications | Clavien-Dindo classification | 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 |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Puppo, MD | Contact | 00390171642867 | puppo.a@ospedale.cuneo.it | |
| Elena Olearo, MD | Contact | 00390171642369 | eolearo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Puppo, MD | Azienda Ospedaliera Santa Croce e Carle Cuneo | Principal Investigator |
| Elena Olearo, MD | Azienda Ospedaliera Santa Croce e Carle Cuneo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Santa Croce e Carle Cuneo | Cuneo | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33849726 | Result | 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. |
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Study data will be shared with investigators from other centers and results published according to national and international regulatory requirements
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Intervention Model: Single Group Assignment
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| 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 |
|
| 2-year progression free survival | 24 months after surgery |
| 2-year overall survival | 24 months after surgery |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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