CellAdhesionMolecule EndometriosisRatio - CAMERA (CAMERA)

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

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 Overview

• Status: Recruiting
• Conditions: Endometriosis (Diagnosis); Identification of Biomarkers in Serum

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lorenz Kuessel, Dr.; Phone Number: +4314040049160; Email: lorenz.kuessel@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University Vienna
    • Contact: Lorenz Kuessel, Dr.; Phone Number: +434040049160; Email: lorenz.kuessel@meduniwien.ac.at
    • Contact: Heinrich Husslein, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

women in reproductive age undergoing a diagnostic laparoscopy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients; participants undergoing a diagnostic laparoscopy and have a histologically confirmed Endometriosis
controls; participants undergoing a diagnostic laparoscopy where no evidence of Endometriosis could be found

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sICAM and sVCAM in serum	levels of these two soluble adhesion factors in serum of patients and controls	up to 1 week

Collaborators and Investigators

• Sponsor: Heinrich Husslein
• Collaborators: Medical-Scientific Fund of the Mayor of the Federal Capital Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 1496/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No