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临床试验/NCT06020482
NCT06020482招募中不适用

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

General University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity

时间窗: The project is supposed to be lasting 3 years.

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.

次要结局

未报告次要终点

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zdenka Lisa

M.D.

General University Hospital, Prague

研究点 (1)

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