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

NCT07321730 | Not Yet Recruiting

• 1 other identifier: 8151
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Visual pattern of ovarian cancer

  To assess the ability of gynecologic oncologic surgeons to visually recognize pathological and molecular features of peritoneal carcinomatosis in advanced ovarian cancer.

  1 month

Secondary Outcomes (1)

• Differences beetween senior and junior surgeons

  1 month

Interventions

VISUAL PC - SURVEY 2.0 OTHER

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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gynecologic oncologists with surgical experience in the management of ovarian cancer, both senior and young surgeons. A senior surgeon is a reference surgeon with a high level of expertise in ovarian cancer (OC) surgery, typically with years of independent surgical practice or holding a leadership or responsible role. The junior surgeon is a surgeon in advanced training or with a few years of experience in complex oncologic surgery for ovarian cancer.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Anna Fagotti

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Fagotti

CONTACT

+390630153502; anna.fagotti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: January 10, 2026
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12