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Trials / Recruiting

RecruitingNCT06020482

Molecular Markes of Fibrosis of Endometriosis and Their Use in Predicting Disease Severity

Molecular Markes of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity

Status
Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
General University Hospital, Prague · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Not accepted

Summary

The primary aim of the project is to analyse gene expression in individual types of ectopic endometrium (ovarian endometriosis, peritoneal endometriosis, deep infiltrating endometriosis) and compare it with gene expression in eutopic endometrium. The analysis focuses on the identification of genes with significantly increased expression in each type of ectopic endometrium and comparison of their expression with the degree of disease, ovarian reserve and clinical manifestations of the disease (pain, infertility).

Detailed description

Endometriosis is defined as the presence of endometrial-like tissue outside the uterine cavity. It is a chronic benign estrogen-dependent disease affecting approximately 10% of women of reproductive age. It significantly affects the quality of life of affected women despite available treatment. The disease is most manifested by symptoms of pain (chronic pelvic pain, dysmenorrhea, dyspareunia, dyschesia) and sterility. In addition to adenomyosis (internal endometriosis), there are three main types of the disease - ovarian endometriosis (OE), peritoneal endometriosis (PE) and deep infiltrating endometriosis (DE). Although it is a benign disease, it shares certain characteristics with malignant diseases, such as the ability to relapse and grow infiltratively. Endometriosis tends to recur and develop adhesions and fibrotic scarring in the abdominal cavity, which means a higher risk of more severe symptoms and organ damage. The origin of the disease remains unclear. Although it is believed that ectopic endometrial cells exhibit molecular abnormalities that promote their ability to adhere and growth outside the uterine cavity. Previous studies have identified various proteins that are up-regulated in endometrial-like tissue compared to normal endometrium, such as ACTA2, ALDH1B, FABP4 or MMP9. However, the diagnostic utility of these biomarkers is limited. In addition, there is no established biomarker that is specific to different types of ectopic endometrium or correlates with disease severity. Therefore, the identification and validation of these molecular abnormalities and proteins appears to be a key point in the effort to elucidate the pathway of disease development. This might open new possibilities for predicting disease progression so that monitoring a treatment of the disease might be tailored to the high-risk patients. The aim of our study is to analyze molecular markers of fibrosis in eutopic and ectopic endometrium in women with endometriosis and compare them with endometrium of women without endometriosis. These markers will be correlated with the clinical state and course of disease before and after treatment. By this analysis we would like to find parameters that may correlate with the severity of the disease, risk of recurrence or postoperative complications.

Conditions

Interventions

TypeNameDescription
OTHERMolecular markes of fibrosis of single types of endometriosis and their use in predicting disease severityThe aim of the study is to analyze molecular markers of fibrosis in female patients with endometriosis vs. without endometriosis. These features will be compared for their clinical status and progression of the disease before and after treatment. Identification and validation of these features appears to be a crucial step in predicting progression of the disease. Moreover, we would be able to modify follow-up and treatment management in high-risk patients for endometriosis.

Timeline

Start date
2023-04-01
Primary completion
2025-12-31
Completion
2026-12-31
First posted
2023-08-31
Last updated
2023-08-31

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT06020482. Inclusion in this directory is not an endorsement.