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临床试验/NCT04990076
NCT04990076招募中不适用

Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2020年3月11日最近更新:
适应症

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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