CellAdhesionMolecule EndometriosisRatio - CAMERA

Heinrich Husslein

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT04294017

1496/2017

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

patients

Description:

participants undergoing a diagnostic laparoscopy and have a histologically confirmed Endometriosis

controls

Description:

participants undergoing a diagnostic laparoscopy where no evidence of Endometriosis could be found