跳至主要内容
临床试验/NCT04579575
NCT04579575Unknown不适用

Added Value of Ovarian-Adnexal Reporting and Data System in Evaluation of Ovarian Lesions

Assiut University0 个研究点目标入组 30 人开始时间: 2021年12月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Added value of Ovarian-Adnexal Reporting and Data System in evaluation of 30 participants with ovarian lesions regarding malignancy rate ,the validity and reliability after comparison with pathology specimens results .

研究概览

简要总结

To detect added value of O-RADS in evaluation of ovarian lesions and compare O-RADS with GI-RADS regarding malignancy rate, the validity and reliability through pathological results and other modalities

详细描述

Ultrasound (US) continues to be the initial imaging modality of choice for the identification and characterization of adnexal masses (AM) . Structured reporting of AM findings was identified by a Society of Radiologists in Ultrasound consensus working group as a target for the investigation to improve the management of women with AM .

Many established guidelines and structured reporting have been developed using sonography to characterize AM, including subjective assessment, simple scoring systems, and statistically derived scoring systems .

In 2008, the International Ovarian Tumor Analysis (IOTA) group proposed the use of US simple rules for the diagnosis of ovarian malignancy. These are based on a set of five US features indicative for a benign tumor (B features), and five US features indicative for a malignant tumor (M features)

. In 2009, the Gynecology Imaging Reporting and Data System (GI-RADS) was designed as an attempt allowing standardized reporting of AM. This system is based on recognition patterns and criteria provided by the IOTA.

The American College of Radiology (ACR) published the Ovarian-Adnexal Reporting and Data System (O-RADS), which provides an up-to-date suggestion to stratify the AM according to sonographic features. The O-RADS offers a comprehensive algorithm that categorizes AM by their possibility of being normal (O-RADS 1), to high risk of malignancy (O-RADS 5) .

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
17 Years 至 75 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •All newly diagnosed patients with ovarian lesions referred to the radiology department.
  • •Must be able to be examined.

排除标准

  • •Patients younger than 17 years old
  • •Patient who refused to be a part of the study and undergo examination.

结局指标

主要结局

Added value of Ovarian-Adnexal Reporting and Data System in evaluation of 30 participants with ovarian lesions regarding malignancy rate ,the validity and reliability after comparison with pathology specimens results .

时间窗: Baseline

Evaluation of the ovarian lesions by Trans-abdominal and Trans-vaginal Ultrasound for diagnosis of ovarian malignancy as early as possible for further management

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

Mahmoud Abdel Maged Mohamed

Principal investigator

Assiut University

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