CellAdhesionMolecule EndometriosisRatio - CAMERA

Endometriosis (Diagnosis) Clinical Trial

— CAMERA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04294017
• Other study ID #: 1496/2017
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Medical University of Vienna
• Contact: Lorenz Kuessel, Dr.
• Phone: +4314040049160
• Email: lorenz.kuessel[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• unfulfilled desire for children

• chronic pelvic pain

• suspicion of endometriosis

• cysts

• myomas

Exclusion Criteria:

• acute infections

• malign diseases

• drug abuse

• pregnancy

• infectious diseases

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis (Diagnosis)
• Identification of Biomarkers in Serum

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich Husslein	Medical-Scientific Fund of the Mayor of the Federal Capital Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sICAM and sVCAM in serum	levels of these two soluble adhesion factors in serum of patients and controls	up to 1 week