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临床试验/NCT04123158
NCT04123158已完成不适用

MYometrial Lesion UltrasouNd And mRi

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 2,353 人开始时间: 2019年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,353
试验地点
1
主要终点
Diagnostic algorithm in predicting uterine sarcoma and STUMP

研究概览

简要总结

A monocentric prospective observational study aimed at assessing the accuracy of a diagnostic algorithm to pre-operatively identify uterine sarcomas..

Primary Aim:The primary outcome is to evaluate the accuracy (sensitivity/specificity) of "Positive Orange Criteria" category in predicting uterine sarcoma and STUMP in the population of patients with > 3 cm myometrial lesions.

详细描述

INTRODUCTION

Uterine sarcomas are rare malignant tumors arising from the mesenchymal tissues of the uterus including the endometrial stroma, uterine muscle and connective tissue. They represent 1% of female genital tract malignancies and 3-7% of all uterine malignances with a worldwide annual incidence of 1.55-1.95 per 100.000 women. Malignant mesenchimal tumors include: uterine leiomyosarcoma (LMS), endometrial stromal sarcoma (ESS), and undifferentiated uterine sarcoma (UUS), and other (eg adenosarcoma, epithelioid sarcoma, STUMP). The current WHO classification also includes a smooth muscle tumor with features that preclude an unequivocal diagnosis of leiomyosarcoma, but do not fulfill the criteria for leiomyoma, or its variants, therefore is defined as smooth uterine muscle of uncertain malignant potential (STUMP). While most STUMP patients have good outcomes, unexpected aggressive behavior can be seen in some of the tumors.

The mean age at diagnosis is approximately 60 years old. However, uterine sarcomas have been diagnosed in women as young as 20 years old . The prevalence of sarcoma in women undergoing hysterectomy or myomectomy for a myometrial mass, is approximately 0.001 percent (1 in 1000) (Parker 94), with a range from 0.005 (1 in 2000) to 0.28 percent (1 in 352). , The discrimination between benign and malignant myometrial lesions is clinically relevant to plan the optimal management (surgery versus medical treatment) and to define the most appropriate surgical approach.

However, the diagnosis of uterine sarcomas or STUMP is a challenge and no validated clinical or radiological criteria can accurately distinguish benign from malignant myometrial tumors.

In particular, data on the ultrasound features of uterine sarcomas are scarce and they are mainly based on retrospective case series. The role of CT(Computed Tomography) has generally been limited to identify extrauterine disease, including local spread within the pelvis and metastatic disease. MRI (Magnetic Resonance Imaging) )represents an accurate diagnostic imaging modality in the assessment of gynecological pathologies with high soft tissue contrast, large field-of-view and multiplanar imaging capabilities; however, no accurate diagnostic criteria have been validated to discriminate between benign and malignant myometrial lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Consecutive patients admitted to our Department for transvaginal ultrasound examination, in whom a myometrial lesion > 3cm in size is detected.
  • Informed consent form signed by the patient.

排除标准

  • Patients undergoing medical treatment for myometrial lesion;
  • Patients previously treated with hormonal therapy including estroprogestin in the last six months;
  • Patients previously treated by embolization

结局指标

主要结局

Diagnostic algorithm in predicting uterine sarcoma and STUMP

时间窗: January 2019- January 2024

the accuracy (sensitivity/specificity) of "Positive Orange Criteria" category in predicting uterine sarcoma and STUMP in the population of patients with \> 3 cm myometrial lesions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CICCARONE FRANCESCA

Medical doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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