跳至主要内容
临床试验/NCT07028229
NCT07028229尚未招募不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
6
试验地点
1
主要终点
Agreement Rate Between Residents and Experts in Ultrasound-Based Staging of Gynecologic Cancers

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Training Group (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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