Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease SeverityMMFNCT06020482
Molecular Markes of Fibrosis of Endometriosis and Their Use in Predicting Disease Severity
An observational study of Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity, run by General University Hospital, Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity
- What is being tested?
- Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women (18-45 years) with or without endmetriosis
Who may be able to join
- women (18-45 years)
- signed informed consent with the study
- absence of hormonal treatment 3 months before the planned procedure
- laparoscopically and histologically confirmed endometriosis dg.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital in Prague
Prague, 12808
Zdenka Lisa, M.D., +420224967003, zdenka.lisa@vfn.cz
Michael Fanta, M.D., 0042224967004, michael.fanta@vfn.cz
About this study
Official title: 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).
Read the 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.
- Being tested
- Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity
- Keywords
- endometriosis, moleculars markers of fibrosis, deep infiltrating endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| A-OE | women with ovarian endometriosis (study group) Receives: Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity | |
| A-PE | women with peitoneal endometriosis (study group) Receives: Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity | |
| A-DE | women with deep infiltrating endometriosis (study group) Receives: Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity | |
| B | women without endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The project is supposed to be lasting 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease SeverityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenka Lisa, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020482
- Sponsor's protocol ID
- GIP-23-L-03-223
- Acronym
- MMF
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markes of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity
- ClinicalTrials.gov ID
- NCT06020482
- Acronym / sponsor ID
- MMF / GIP-23-L-03-223
- Keywords
- endometriosis, moleculars markers of fibrosis, deep infiltrating endometriosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A-OE | – | Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severitywomen with ovarian endometriosis (study group) |
| A-PE | – | Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severitywomen with peitoneal endometriosis (study group) |
| A-DE | – | Other: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severitywomen with deep infiltrating endometriosis (study group) |
| B | – | –women without endometriosis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women (18-45 years) with or without endmetriosis
Key inclusion criteria (7 listed)
- women (18-45 years)
- signed informed consent with the study
- absence of hormonal treatment 3 months before the planned procedure
- laparoscopically and histologically confirmed endometriosis dg.
- patients without endometriosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular 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. | Other | A-DE, A-OE, A-PE |
Primary outcome
Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity (time frame: The project is supposed to be lasting 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.