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临床试验/NCT04294017
NCT04294017Unknown不适用

The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study

Heinrich Husslein1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
sICAM and sVCAM in serum

研究概览

简要总结

Background: Endometriosis, which is characterized by the growth of endometrial stroma and glands outside of the uterine cavity, is estimated to occur in 6-10% of women of reproductive age. Clinical presentation of endometriosis can vary widely, often significantly reducing quality of life, and the mean interval between the onset of symptoms and obtaining a definitive diagnosis is approximately 10 years. Currently, laparoscopy is the gold standard for diagnosing endometriosis; however, this procedure is invasive, carries surgery-related risks, and contributes to diagnostic delay. Therefore, the field has an urgent need for an efficient, sensitive, non-invasive tool for diagnosing endometriosis.

Recently, it was shown that sVCAM-1/sICAM-1 ratio is a promising serum biomarker, which may lead to the development of a new, efficient, sensitive, non-invasive tool for diagnosing endometriosis, thereby potentially avoiding surgical interventions.

Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis.

Study design: Prospective multicenter validation study

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • unfulfilled desire for children
  • chronic pelvic pain
  • suspicion of endometriosis

排除标准

  • acute infections
  • malign diseases
  • drug abuse
  • pregnancy
  • infectious diseases

结局指标

主要结局

sICAM and sVCAM in serum

时间窗: up to 1 week

levels of these two soluble adhesion factors in serum of patients and controls

次要结局

未报告次要终点

研究者

发起方
Heinrich Husslein
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Heinrich Husslein

Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M.

Medical University of Vienna

研究点 (1)

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