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临床试验/NCT02247323
NCT02247323Unknown不适用

Ovarian Malignancy Incidence in Premenopausal Women Who Were at Moderate Risk for Malignancy by Risk of Malignancy Index With Low CA 125.(Retrospective Study)

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Incidence of ovarian malignancy

研究概览

简要总结

The investigators are assessing the incidence of ovarian cancer in premenopausal women who were at moderate risk of malignancy with low CA125.

详细描述

About 10% of premenopausal women may have a surgery for ovarian masses. In premenopausal women the incidence of ovarian malignancy is 1:1000 in case of symptomatic ovarian cyst.1 CA125 is unreliable in differentiating benign from malignant ovarian mass in premenopausal women due to many false positive results and reduced specificity.1 pelvic vaginal ultrasonography is the most effective tool in evaluating ovarian masses due to increased sensitivity over abdominal US.1 An estimation of risk of malignancy index is essential in evaluating an ovarian mass.26 /2 Risk of malignancy index combines presurgical features serum including CA125, menopausal status and ultrasound findings. RMI=Ux Mx CA125 in which each feature takes a score and after calculation score less than 25 is mild, from 25-250 moderate and more than 250 has a severe risk of malignancy needing oncologist.44/3

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
45 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with complex ovarian cyst
  • Abdominal pain
  • Menometrorrhagia

排除标准

  • Significant weight loss
  • History of ovarian or other malignancy
  • Family history of ovarian Cancer

结局指标

主要结局

Incidence of ovarian malignancy

时间窗: one year

Calculation of number of women who had ovarian cancer after an operation in moderate risk

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

Nesreen Abdel Fattah Abdullah Shehata

Assistant Professor of Obstetrics and Gynecology

Beni-Suef University

研究点 (1)

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