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NCT Number: NCT07028229

Ultrasound Training Program for Gynecologic Cancer Staging in Residents

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.

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Key information

Conditions

Medical Education Adnexal Diseases Cervix Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ultrasound Training Program for Gynecologic Cancer Staging

Primary outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Carla Testa

CONTACT

[email protected]

0630156399

Francesca Moro

CONTACT

[email protected]

0630156399

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Development and Validation of an Ultrasound Training Program for Residents in Staging Gynecological Cancers (Ovarian Cancer, Endometrial Cancer and Cervical Cancer)

Acronym: Ultra-teaching

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jun 19, 2025
Registry last updated: Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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