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Surgeons' Ability to Predict Pathological and Molecular Features of Peritoneal Carcinomatosis in Ovarian Cancer

NCT07321730 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-01-07

No results posted yet for this study

Summary

Epithelial ovarian cancer (EOC) presents with peritoneal carcinomatosis (PC) at diagnosis in approximately two-thirds of cases. Diagnostic laparoscopy is pivotal to assess disease extent and to guide the choice between primary cytoreductive surgery (PCS) and neoadjuvant chemotherapy followed by interval cytoreductive surgery (ICS). The Predictive Index Value (PIV) provides a quantitative estimate of resectability, but it does not systematically capture qualitative intraoperative descriptors. Growing evidence suggests that macroscopic features (e.g., nodularity, plaques, omental cake, infiltrative vs expansile growth, margin definition, vascularization, and tissue retraction) may correlate with histotype and molecular profile, and possibly with chemosensitivity. However, surgeons' ability to recognize these visual patterns in a standardized manner has not been systematically investigated.

This cross-sectional survey will assess whether gynecologic oncologic surgeons managing PC can: distinguish malignant metastases from benign tumor-like lesions; associate morphologic patterns with tumor histotypes (type I vs type II EOC and ovarian metastases from other primaries); classify high-grade serous ovarian cancer (HGSOC) growth pattern as infiltrative vs exophytic/expansile; and infer molecular status from macroscopic appearance. The secondary objective is to compare accuracy and confidence between senior and junior surgeons.

Seventy to eighty surgeons will complete an online survey (Microsoft Forms) presenting anonymized laparoscopic images retrospectively selected from routinely recorded diagnostic-laparoscopy videos of 19 consented patients with advanced EOC and PC. Participants will classify each case using predefined categories and rate confidence on a 5-point Likert scale. Analyses will be primarily descriptive (counts/percentages); senior vs junior comparisons will use χ²/Fisher's exact tests for categorical variables and the Mann-Whitney U test for ordinal measures, as appropriate.

Conditions

Interventions

OTHER

VISUAL PC - SURVEY 2.0

Survey for surgeons in order to study their ability to recognize macroscopic features for selecting appropriate treatment strategies in patients with abdominal malignancies.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Anna Fagotti · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2026-03-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07321730 on ClinicalTrials.gov