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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity
• Intervention / Treatment: Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 12808
    • Recruiting
    • General University Hospital in Prague
    • Contact: Zdenka Lisa, M.D.; Phone Number: +420224967003; Email: zdenka.lisa@vfn.cz
    • Contact: Michael Fanta, M.D.; Phone Number: 0042224967004; Email: michael.fanta@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women (18-45 years) with or without endmetriosis

Description

Inclusion Criteria:

• women (18-45 years)
• signed informed consent with the study
• absence of hormonal treatment 3 months before the planned procedure

Inclusion criteria for group A:

- laparoscopically and histologically confirmed endometriosis dg.

Inclusion criteria for group B:

• patients without endometriosis
• patients who are undergoing an elective laparoscopic or hysteroscopic procedure in our department for another benign indication
• patients with excluded malignant disease

Exclusion Criteria:

• absence of informed consent
• patients who do not meet the inclusion criteria during surgery
• patient younger than 18 years of age or older than 45 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A-OE; women with ovarian endometriosis (study group)	Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity; The 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.
A-PE; women with peitoneal endometriosis (study group)	Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity; The 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.
A-DE; women with deep infiltrating endometriosis (study group)	Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity; The 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.
B; women without endometriosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity	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.	The project is supposed to be lasting 3 years.

Collaborators and Investigators

• Sponsor: General University Hospital, Prague

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: endometriosis, moleculars markers of fibrosis, deep infiltrating endometriosis
• Additional Relevant MeSH Terms: Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Fibrosis; Endometriosis
• Other Study ID Numbers: GIP-23-L-03-223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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