跳至主要内容
临床试验/NCT06795711
NCT06795711招募中不适用

Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 465 人开始时间: 2022年4月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
465
试验地点
1
主要终点
Definition of uterine biometric parameters

研究概览

简要总结

Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity

详细描述

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:

  • Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding.
  • Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases.
  • Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age between 18 and 60;
  • obtaining informed consent

排除标准

  • Hysterectomised patients;
  • Virgo patients (hymenal integrity);
  • Patients reporting intolerance to transvaginal ultrasound;
  • Gynaecological oncology;
  • Recent pregnancy or childbirth (within 6 months);
  • Menopausal patients

结局指标

主要结局

Definition of uterine biometric parameters

时间窗: After enrollment on first visit

Definition of uterine biometric parameters for the diagnosis of adenomyotic uterus (group A), fibromatous uterus (group B) and normal uterus (group C) by means of transvaginal ultrasound, performed as per the care procedure. Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off

Diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis

时间窗: After enrollment on first visit

Evaluation of the diagnostic capacity of 'globular uterus' for the diagnosis of adenomyosis as an additional parameter to those already known in the literature with possible subsequent identification of a biometric cut-off

次要结局

  • Construction of deep learning models on uterine ultrasound images(After enrollment on first visit)
  • Evaluation of diagnostic accuracy of deep learning validated(After enrollment on first visit)
  • Identification of the frequency of finding ultrasound signs of adenomyosis in the cervix(After enrollment on first visit)
  • Evaluation of diagnostic accuracy(After enrollment on first visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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