RecruitingNCT04990076

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

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1,500 participants

Start Date

Mar 11, 2020

Study Type

OBSERVATIONAL

Conditions

Sarcoma Uterus Myoma;Uterus

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares ultrasound images of the uterus (using a standardized method called MUSA) with tissue samples taken after surgery to better understand uterine conditions like fibroids and adenomyosis. The goal is to improve how doctors use ultrasound to diagnose these conditions before surgery. **You may be eligible if...** - You are 18 or older - You are scheduled for a hysterectomy (uterus removal) due to a uterine condition such as a fibroid, focal adenomyosis, or uterine sarcoma - Your uterine lesion is larger than 1 cm **You may NOT be eligible if...** - You have many fibroids throughout the uterus - Your uterine lesion is smaller than 10 mm - You are currently being treated for another cancer - You also have ovarian, endometrial, or cervical conditions - You do not consent to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHysterectomy

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.

Locations(1)

UZ Leuven

Leuven, Belgium

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