Surgeons' Ability to Predict Pathological and Molecular Features of Peritoneal Carcinomatosis in Ovarian Cancer (Visual-PC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Fagotti
- Phone Number: +390630153502
- Email: anna.fagotti@policlinicogemelli.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual pattern of ovarian cancer
Time Frame: 1 month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences beetween senior and junior surgeons
Time Frame: 1 month
|
To compare diagnostic accuracy between senior and junior surgeons.
|
1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anna Fagotti, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
Other Study ID Numbers
- 8151
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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