Early Stage Ovarian Tumors, Peritoneal Carcinosis
Conditions
Keywords
ovarian cancer, early stage, ovarian tumor, peritoneal carcinosis, pathology assessment
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
Interventions
PROCEDUREsystematic 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_TESTHistopathologic 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
Sponsors
Ospedale Santa Croce-Carle Cuneo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Intervention Model: Single Group Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | from the date of surgery up to six months after surgery | Clavien-Dindo classification |
| 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 | — |
Countries
Italy
Contacts
Primary ContactAndrea Puppo, MD
Backup ContactElena Olearo, MD
Outcome results
None listed