The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
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
- 是
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
Heinrich Husslein
Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M.
Medical University of Vienna
