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Clinical Trial NCT06020482 (MMF) for Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Molecular Markes of Fibrosis of Endometriosis and Their Use in Predicting Disease Severity (MMF) 120
Clinical Trial NCT06020482 (MMF) is an observational study for Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity that is recruiting. It started on 1 April 2023 with plans to enroll 120 participants. Led by General University Hospital, Prague, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 31 August 2023.
Brief 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 d...Show More
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...Show More
Official Title
Molecular Markes of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity
Conditions
Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease SeverityOther Study IDs
- MMF
- GIP-23-L-03-223
NCT ID Number
Start Date (Actual)
2023-04-01
Last Update Posted
2023-08-31
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
120
Study Type
Observational
Status
Recruiting
Keywords
endometriosis, moleculars markers of fibrosis, deep infiltrating endometriosis
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
A-OE women with ovarian endometriosis (study group) | 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 tre...Show More |
A-PE women with peitoneal endometriosis (study group) | 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 tre...Show More |
A-DE women with deep infiltrating endometriosis (study group) | 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 tre...Show More |
B women without endometriosis | N/A |
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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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
- 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 Responsible Party
Zdenka Lisa, Principal Investigator, M.D., General University Hospital, Prague
No contact data.
1 Study Locations in 1 Countries
General University Hospital in Prague, Prague, 12808, Czechia
Zdenka Lisa, M.D., Contact, +420224967003, [email protected]
Michael Fanta, M.D., Contact, 0042224967004, [email protected]
Recruiting