Clinical trial NCT04990076: Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology
Official title: Ultrasound Evaluation of the Myometrium Using the MUSA Terminology, Comparison With Histology.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myoma;Uterus
Sarcoma Uterus
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for hysterectomy with a myometrial lesion

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 The estimation for sarcomas is based on preliminary and unpublished results from an ongoing prospective study led by prof dr Antonia Testa from the Università Cattolica di Sacro Cuore Largo Agostino Gemelli in Rome showing an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

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of the MUSA terms and definitions
timeFrame: 4 years
Secondary outcomes:
measure: Development of prediction model
timeFrame: 5 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Dirk Timmerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van den Bosch T, Dueholm M, Leone FP, Valentin L, Rasmussen CK, Votino A, Van Schoubroeck D, Landolfo C, Installe AJ, Guerriero S, Exacoustos C, Gordts S, Benacerraf B, D'Hooghe T, De Moor B, Brolmann H, Goldstein S, Epstein E, Bourne T, Timmerman D. Terms, definitions and measurements to describe sonographic features of myometrium and uterine masses: a consensus opinion from the Morphological Uterus Sonographic Assessment (MUSA) group. Ultrasound Obstet Gynecol. 2015 Sep;46(3):284-98. doi: 10.1002/uog.14806. Epub 2015 Aug 10.
citation: Ludovisi M, Moro F, Pasciuto T, Di Noi S, Giunchi S, Savelli L, Pascual MA, Sladkevicius P, Alcazar JL, Franchi D, Mancari R, Moruzzi MC, Jurkovic D, Chiappa V, Guerriero S, Exacoustos C, Epstein E, Fruhauf F, Fischerova D, Fruscio R, Ciccarone F, Zannoni GF, Scambia G, Valentin L, Testa AC. Imaging in gynecological disease (15): clinical and ultrasound characteristics of uterine sarcoma. Ultrasound Obstet Gynecol. 2019 Nov;54(5):676-687. doi: 10.1002/uog.20270. Epub 2019 Oct 7.