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临床试验/NCT01337999
NCT01337999Unknown不适用

Human Epididymis Protein 4 in Normal Menstruating Women

Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
HE-4 level

研究概览

简要总结

The purpose of this study is to determine if Human Epididymis Protein 4 (HE-4) levels vary during the menstrual cycles in ovulatory women. HE-4 is a sensitive serological marker that is elevated in certain ovarian and endometrial cancers and can aid in the diagnosis of these malignant conditions. In order to optimize the utility of HE4 as a tumor marker in premenopausal women, its expression in the normal menstrual cycle needs to be characterized. We hypothesize that HE-4 levels do not vary in the menstrual cycle.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women age 18-45 years old
  • regular menstrual cycles (every 25-35 days)
  • normal BMI (19-25)
  • no hormonal contraception in the two menstrual cycles prior to enrollment

排除标准

  • pregnancy
  • pelvic mass

结局指标

主要结局

HE-4 level

时间窗: 5 times during menstrual cycle

次要结局

未报告次要终点

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Plante

Beth Plante, M.D.

Women and Infants Hospital of Rhode Island

研究点 (1)

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