CellAdhesionMolecule EndometriosisRatio - CAMERA

NCT04294017 | Unknown

• 1 other identifier: 1496/2017
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis (Diagnosis); Identification of Biomarkers in Serum

Outcome Measures

Primary Outcomes (1)

• sICAM and sVCAM in serum

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

  up to 1 week

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women in reproductive age undergoing a diagnostic laparoscopy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heinrich Husslein: lead
• Medical-Scientific Fund of the Mayor of the Federal Capital Vienna: collaborator

Study Sites (1)

Medical University Vienna

Vienna, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 4 ml of serum per participant

MeSH Terms

Conditions

Endometriosis; Disease

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lorenz Kuessel, Dr.

CONTACT

+4314040049160; lorenz.kuessel@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc.Prof.Priv.Doz Dr.med.univ. , PLL.M.

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: March 3, 2020
• Study Start: November 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

AU (1)