Ultrasound Training Program for Gynecologic Cancer Staging in Residents

Not Applicable

Not yet recruiting

• Conditions: Medical Education; Ovarian Cancer; Endometrial Cancer; Cervix Cancer

• Registration Number: NCT07028229
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This is a prospective, interventional study aiming to develop and validate an ultrasound training program for gynecology and obstetrics residents, focused on the staging of gynecologic cancers, including ovarian, endometrial, and cervical cancer. The program consists of theoretical lectures, practical hands-on sessions, and supervised clinical case evaluations over a six-month period. Residents will perform ultrasound examinations independently, which will be compared to those conducted by expert sonographers. The primary objective is to assess the learning curve of each trainee by evaluating diagnostic concordance with expert findings across specific staging parameters.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study Start: 2025-06-16
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• At least six gynecology residents who will regularly attend the ultrasound center daily, with overlapping shifts.
• All patients with a diagnosis or suspected diagnosis of gynecological cancer, including ovarian, endometrial, and cervical cancers, will be included in the study and scanned by both residents and experts.
• Signing of the informed consent by the participants.

Exclusion Criteria

• non-gynecology specialists, with attendance schedules at the center other than daily.
• Failure to sign the informed consent by the participants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers	Up to 6 months (from the start to the end of the training program)	Assessment of the diagnostic concordance between ultrasound staging performed by residents and expert sonographers, measured across defined anatomical and pathological parameters (e.g., lymph node involvement, carcinomatosis, tumor size and spread). Concordance will be quantified as the percentage of agreement per case and per parameter.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy