Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the MUSA terms and definitions
研究概览
简要总结
The main objective is to evaluate the diagnostic accuracy of the MUSA terms and definitions, as defined in the paper by Van den Bosch T, Dueholm M, ea. in 2015, to differentiate between different types of myometrial lesions of more than 1 cm. The primary aim is the diagnostic accuracy of the MUSA terms and definitions and the secondary aim the development of a prediction model.
详细描述
Primary aim: Diagnostic accuracy of the MUSA terms and definitions
Every patient planned for hysterectomy for myometrial pathology (e.g. benign fibroid, benign adenomyoma or malignant uterine sarcoma) will undergo a systematic preoperative ultrasound scan. Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an incidence of 4.9% for uterine sarcomas amongst women with a myometrial lesion referred to their tertiary center (Antonia Testa, personal communication).
Secondary aim: Development of prediction model
The Secondary aim is to build predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma). Because of the small number of cases with malignant myometrial lesion (expected to be 5% of the study population or around 75 women), we will limit the number of variables to be tested in order to avoid overfitting. Based on current literature, we preselected following characteristics for development of a prediction model:
- Outer contour: regular of irregular
- Echogenicity of uterine lesion: uniform (homogeneous) or non-uniform (mixed)
- Colour score: 1 to 4
- Presence of central necrosis
- Maximal diameter of the lesion (in mm)
- Presence of acoustic shadows
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma).
排除标准
- •Patient's refusal
- •Age < 18 years
- •Polymyomatous uterus
- •Myometrial lesion with a diameter less then 10mm
- •Patients currently treated for another cancer
- •Patients with ovarian pathology, endometrial pathology of cervical pathology
- •Power morcellation
结局指标
主要结局
Diagnostic accuracy of the MUSA terms and definitions
时间窗: 4 years
Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions).
次要结局
- Development of prediction model(5 years)
