跳至主要内容
临床试验/CTRI/2023/05/052553
CTRI/2023/05/052553尚未招募不适用

Diagnostic Efficacy of Ultrasonographic Scoring Systems and Clinical Profile in differentiating Benign and Malignant Adnexal Masses

Postgraduate Institute of Medical Education & Research Chandigarh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.Calculate the diagnostic accuracy of O-RADS Ultrasonographic scoring system to differentiate benign and malignant adnexal masses with pathological findings as reference standard

研究概览

简要总结

Differential diagnosis of adnexal masses, especially those of ovarian origin, may be a challenge clinically and radiologically. Inconsistency while describing morphology of the lesion often results in significant differences in subsequent interpretations. The use of internationally agreed upon standardized systems help reduce inter observer variability in reports, thus increasing the probability of a correct diagnosis. Various prediction models have been developed to assist clinicians to determine the risk of malignancies in adnexal masses. This helps deciding the appropriate treatment strategy suited for the patient. Risk of Malignancy Index (RMI) was the first of such systems. Subsequently, other scoring systems including IOTA SR, IOTA LR, O-RADS, GI-RADS and most recently, the IOTA ADNEX score have been introduced.

The available radiological scoring systems were established and tested based on data obtained from European populations. These systems need to be more widely validated in practice with various ethnic populations. Our study aims to compare the diagnostic efficacy of the O-RADS, IOTA SR, IOTA ADNEX rules for predicting benign and malignant ovarian tumours in the Indian population.

研究设计

研究类型
Observational

入排标准

年龄范围
13.00 Year(s) 至 80.00 Year(s)(—)
性别
Female

入选标准

  • 100 women presenting to Gynaecology OPD with Adnexal Masses.

排除标准

  • 1.Refusal to give consent 2.Women with follicular cysts and corpus luteal cysts <3 cm (O-RADS 1) 3.Women without pathological diagnosis and / or insufficient follow up.

结局指标

主要结局

1.Calculate the diagnostic accuracy of O-RADS Ultrasonographic scoring system to differentiate benign and malignant adnexal masses with pathological findings as reference standard

时间窗: 1 year

次要结局

  • Assessment of change in the radiological characteristics during follow-up USG of ORADS 2 lesions(1 year)
  • Diagnostic accuracy of other US Scoring systems i.e. RMI 4, IOTA SR and ADNEX Rules(1 year)
  • Identify descriptors of Adnexal masses on various US scoring systems and their association with different pathologies(1 year)

研究者

发起方
Postgraduate Institute of Medical Education & Research Chandigarh
申办方类型
Government medical college

研究点 (1)

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