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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (described in Addendum 1) will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). Figure 1 shows the different histological endpoint with expected prevalence in our study population and table 1 further differentiate those histological endpoints. The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

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

Conditions
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Myoma;Uterus, Sarcoma Uterus

Intervention / Treatment
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* Procedure: Hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients planned to undergo hysterectomy for myometrial pathology of more then 1cm (e.g. fibroid, focal adenomyosis, uterine sarcoma). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients planned for hysterectomy with a myometrial lesion of more than 1 cm.<br> | Procedure: Hysterectomy<br>* Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the MUSA terms and definitions | Around 50 ultrasound characteristics will be assess as to diagnostic accuracy as predictors (Prospective evaluation of MUSA terms and definitions). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of prediction model | predictive models to differentiate between benign myometrial lesions (e.g. adenomyosis and fibroid) and malignant myometrial lesion (e.g. uterine sarcoma). | 5 years |