The Soluble VCAM-1 / Soluble ICAM-1 Ratio as a Non-invasive Biomarker for Diagnosing Endometriosis - a Prospective Multicenter Validation Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- sICAM and sVCAM in serum
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •unfulfilled desire for children
- •chronic pelvic pain
- •suspicion of endometriosis
Exclusion Criteria
- •acute infections
- •malign diseases
- •drug abuse
- •pregnancy
- •infectious diseases
Outcomes
Primary Outcomes
sICAM and sVCAM in serum
Time Frame: up to 1 week
levels of these two soluble adhesion factors in serum of patients and controls
Secondary Outcomes
No secondary outcomes reported
Investigators
Heinrich Husslein
Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M.
Medical University of Vienna