跳至主要内容
临床试验/CTRI/2024/01/062051
CTRI/2024/01/062051进行中(未招募)不适用

ORADS in evaluation of adnexal masses

Dr Ayushi Raj1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2024年2月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
324
试验地点
1
主要终点
Accuracy of ORADS in differentiating benign and malignant adnexal masses

研究概览

简要总结

The study included 150 women with adnexal lesion who underwent surgical intervention. The ultrasound findings were recorded as per O’RADS classification and O’RADS categories were tested for accuracy against histopathology.

·       The study cohort had women aged 12- 72years with the mean age of 35.89 years.

·       63 (42%) of women had normal BMI and 87 (58%) women had BMI >25 kg/m².

·       There were 83 (55.3%) participants who were nulliparous and 67 (44.7%) were multiparous.

·       Nearly one-third {43 (28.7%)} of the participants had history of infertility. 28 (18.7%) women were known case of endometriosis and 22 (14.7%) were postmenopausal.

·       There were 50 (33.3%) women who were co morbid and 5 (3.3%) had family history of cancer.

·       Out of 150, 131 (87.3%) were non-malignant and 19 were malignant (12.7%) which included 6 borderline tumours.

·       O’RADS category 2 (benign) had 74 cases and 100% were benign, category 3 (low risk) had 32 cases in which only 1 (3.1%) was malignant, category 4 (intermediate risk) had 38 cases in which 12 (31.6%) were malignant and category 5 had 6 cases and 100% were malignant.

·       Among the ultrasound parameters, features significantly associated with malignancy were colour score, ascites, solid areas, inner margins and number of papillary projections.

·       O’RADS 4 had the highest false positive cases among all categories. Ultrasound parameters resulting in maximum false positives were number of locule, solid areas and number of papillary projections.

·       Taking O’RADS 4 as the appropriate cutoff for malignancy, the diagnostic accuracy of O’RADS was 82.7% with sensitivity of 94.7% and specificity of 80.9%.

·       Statistically significant relationship was seen between O’RADS risk of malignancy and final impression. (p <0.001).

研究设计

研究类型
Observational

入排标准

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

入选标准

  • (1) presence of at least one adnexal lesion detected by transvaginal or transabdominal ultrasonography like: Simple ovarian cyst, ectopic, ovarian tumors, tubal or broad ligament neoplasms etc.
  • (2) lesion removed surgically and evaluated histopathologically.
  • (3) time interval between ultrasound detection and surgery not exceeding 30 days.

排除标准

  • (1)women with adnexal lesion not removed surgically or not evaluated histopathologically.
  • (2) women on conservative management and follow up.

结局指标

主要结局

Accuracy of ORADS in differentiating benign and malignant adnexal masses

时间窗: 1 year 4 months

次要结局

未报告次要终点

研究者

发起方
Dr Ayushi Raj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ayushi Raj

KMC, Manipal

研究点 (1)

Loading locations...

相似试验