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临床试验/NCT01738269
NCT01738269已完成不适用

A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population

Chinese PLA General Hospital9 个研究点 分布在 1 个国家目标入组 2,351 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,351
试验地点
9
主要终点
Establish reference in Chinese population

研究概览

简要总结

Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Establish reference in Chinese population

时间窗: October 2012 - March 2013

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yaping Tian

Director of Biochemistry Department

Chinese PLA General Hospital

研究点 (9)

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