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临床试验/NCT03442881
NCT03442881Unknown不适用

The Use of International Ovarian Tumor Analysis and Assessment of Different Neoplasia in the Adnexa Model in Differentiating Malignant and Benign Adnexal Masses

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Nature of the mass

研究概览

简要总结

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

详细描述

All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter.
  • Patients who will undergo surgical intervention .
  • Patients are recruited regardless of age, parity and complaint

排除标准

  • Patients treated with conservative management.
  • Patients known to be pregnant.

结局指标

主要结局

Nature of the mass

时间窗: At time of surgery

Benign or malignant criteria of the excised adnexal mass

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

Ahmed Maged

professor

Cairo University

研究点 (1)

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