Ultrasound Training Program for Gynecologic Cancer Staging in Residents

NCT07028229 | Not Yet Recruiting

• 1 other identifier: 7738
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Education; Ovarian Cancer; Endometrial Cancer; Cervix Cancer

Keywords

Resident Training; Learning Curve; Gynecologic Oncology; Transvaginal Ultrasound

Outcome Measures

Primary Outcomes (1)

• Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers

  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.

  Up to 6 months (from the start to the end of the training program)

Study Arms (1)

Training Group

EXPERIMENTAL

Gynecology and obstetrics residents enrolled in a structured ultrasound training program focused on staging of gynecologic cancers. The program includes theoretical lessons, supervised hands-on sessions, and independent ultrasound assessments compared with expert findings.

Behavioral: Training Group

Interventions

Training Group BEHAVIORAL

A structured educational and practical training program in gynecologic oncology ultrasound designed for residents. The intervention includes lectures, clinical case discussions, supervised and independent ultrasound examinations, and performance assessments to evaluate learning progression and diagnostic concordance with experts.

Also known as: Ultrasound Training Program for Gynecologic Cancer Staging

Training Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study enrolls female patients diagnosed or suspected of having gynecologic cancers (ovarian, endometrial, or cervical cancer) who undergo ultrasound examinations. Medical residents of any gender specializing in gynecology and obstetrics are eligible to participate as trainees in the ultrasound training program.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms

Interventions

Sensitivity Training Groups

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; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Antonia Carla Testa

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Carla Testa

CONTACT

0630156399; antoniacarla.testa@policlinicogemelli.it

Francesca Moro

CONTACT

0630156399; francesca.moro@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 16, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

IT (1)