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Not yet recruiting NCT07321730

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

Observational Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VISUAL PC - SURVEY 2.0.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • Visual pattern of ovarian cancer [Time frame: 1 month]
Secondary outcome measures (1)
  • Differences beetween senior and junior surgeons [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

  • Gynecologic oncologists involved in the surgical management of ovarian cancer
  • Gynecology oncology surgeons with a high level of expertise in OC surgery, with years of independent surgical practice
  • Gynecology oncology surgeons holding a leading/responsible position.
  • Gynecology oncology surgeons in training in oncologic surgery for ovarian cancer.
  • Gynecology oncology surgeons with few years of experience in oncologic surgery for ovarian cancer.
  • Patients with advanced OC who underwent diagnostic laparoscopy, with the intra- operative video available as part of routine clinical practice.
  • The patient's written informed consent will be required to authorize the use of images extracted from diagnostic laparoscopy videos.
  • The informed consent of the participating gynecologic oncologists will be collected electronically through the survey (e.g., via checkbox or digital acceptance).

Exclusion criteria

  • Surgeons not involved in the surgical management of ovarian cancer.
  • Incomplete questionnaires or questionnaires not completed according to the provided instructions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07321730 · 8151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗