xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06020482</url>
    </required_header>
    <id_info>
      <org_study_id>GIP-23-L-03-223</org_study_id>
      <nct_id>NCT06020482</nct_id>
    </id_info>
    <brief_title>Molecular Markes of Fibrosis of Endometriosis and Their Use in Predicting Disease Severity</brief_title>
    <acronym>MMF</acronym>
    <official_title>Molecular Markes of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>General University Hospital, Prague</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>General University Hospital, Prague</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary aim of the project is to analyse gene expression in individual types of ectopic&#xD;
        endometrium (ovarian endometriosis, peritoneal endometriosis, deep infiltrating&#xD;
        endometriosis) and compare it with gene expression in eutopic endometrium. The analysis&#xD;
        focuses on the identification of genes with significantly increased expression in each type&#xD;
        of ectopic endometrium and comparison of their expression with the degree of disease, ovarian&#xD;
        reserve and clinical manifestations of the disease (pain, infertility).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Endometriosis is defined as the presence of endometrial-like tissue outside the uterine&#xD;
        cavity. It is a chronic benign estrogen-dependent disease affecting approximately 10% of&#xD;
        women of reproductive age. It significantly affects the quality of life of affected women&#xD;
        despite available treatment. The disease is most manifested by symptoms of pain (chronic&#xD;
        pelvic pain, dysmenorrhea, dyspareunia, dyschesia) and sterility. In addition to adenomyosis&#xD;
        (internal endometriosis), there are three main types of the disease - ovarian endometriosis&#xD;
        (OE), peritoneal endometriosis (PE) and deep infiltrating endometriosis (DE). Although it is&#xD;
        a benign disease, it shares certain characteristics with malignant diseases, such as the&#xD;
        ability to relapse and grow infiltratively. Endometriosis tends to recur and develop&#xD;
        adhesions and fibrotic scarring in the abdominal cavity, which means a higher risk of more&#xD;
        severe symptoms and organ damage.&#xD;
  &#xD;
        The origin of the disease remains unclear. Although it is believed that ectopic endometrial&#xD;
        cells exhibit molecular abnormalities that promote their ability to adhere and growth outside&#xD;
        the uterine cavity. Previous studies have identified various proteins that are up-regulated&#xD;
        in endometrial-like tissue compared to normal endometrium, such as ACTA2, ALDH1B, FABP4 or&#xD;
        MMP9. However, the diagnostic utility of these biomarkers is limited. In addition, there is&#xD;
        no established biomarker that is specific to different types of ectopic endometrium or&#xD;
        correlates with disease severity. Therefore, the identification and validation of these&#xD;
        molecular abnormalities and proteins appears to be a key point in the effort to elucidate the&#xD;
        pathway of disease development. This might open new possibilities for predicting disease&#xD;
        progression so that monitoring a treatment of the disease might be tailored to the high-risk&#xD;
        patients.&#xD;
  &#xD;
        The aim of our study is to analyze molecular markers of fibrosis in eutopic and ectopic&#xD;
        endometrium in women with endometriosis and compare them with endometrium of women without&#xD;
        endometriosis. These markers will be correlated with the clinical state and course of disease&#xD;
        before and after treatment. By this analysis we would like to find parameters that may&#xD;
        correlate with the severity of the disease, risk of recurrence or postoperative&#xD;
        complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Molecular markers of fibrosis of single types of endometriosis and their use in predicting disease severity</measure>
      <time_frame>The project is supposed to be lasting 3 years.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Molecular Markers of Fibrosis of Single Types of Endometriosis and Their Use in Predicting Disease Severity</condition>
    <arm_group>
      <arm_group_label>A-OE</arm_group_label>
      <description>women with ovarian endometriosis (study group)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A-PE</arm_group_label>
      <description>women with peitoneal endometriosis (study group)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A-DE</arm_group_label>
      <description>women with deep infiltrating endometriosis (study group)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>B</arm_group_label>
      <description>women without endometriosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity</intervention_name>
      <description>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.</description>
      <arm_group_label>A-DE</arm_group_label>
      <arm_group_label>A-OE</arm_group_label>
      <arm_group_label>A-PE</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        specimen of eutopic endometrium and non-eutopic endometrial-like tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          women (18-45 years) with or without endmetriosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  women (18-45 years)&#xD;
  &#xD;
            -  signed informed consent with the study&#xD;
  &#xD;
            -  absence of hormonal treatment 3 months before the planned procedure&#xD;
  &#xD;
          Inclusion criteria for group A:&#xD;
  &#xD;
          - laparoscopically and histologically confirmed endometriosis dg.&#xD;
  &#xD;
          Inclusion criteria for group B:&#xD;
  &#xD;
            -  patients without endometriosis&#xD;
  &#xD;
            -  patients who are undergoing an elective laparoscopic or hysteroscopic procedure in our&#xD;
               department for another benign indication&#xD;
  &#xD;
            -  patients with excluded malignant disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  absence of informed consent&#xD;
  &#xD;
            -  patients who do not meet the inclusion criteria during surgery&#xD;
  &#xD;
            -  patient younger than 18 years of age or older than 45 years of age&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>General University Hospital in Prague</name>
        <address>
          <city>Prague</city>
          <zip>12808</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zdenka Lisa, M.D.</last_name>
        <phone>+420224967003</phone>
        <email>zdenka.lisa@vfn.cz</email>
      </contact>
      <contact_backup>
        <last_name>Michael Fanta, M.D.</last_name>
        <phone>0042224967004</phone>
        <email>michael.fanta@vfn.cz</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>General University Hospital, Prague</investigator_affiliation>
      <investigator_full_name>Zdenka Lisa</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <keyword>endometriosis, moleculars markers of fibrosis, deep infiltrating endometriosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometriosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06020482
  org study id: GIP-23-L-03-223
  nct id: NCT06020482
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  observational model: Case-Control
  time perspective: Prospective
  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.
  description: 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.
  arm group label: A-OE
  description: women with ovarian endometriosis (study group)
  arm group label: A-PE
  description: women with peitoneal endometriosis (study group)
  arm group label: A-DE
  description: women with deep infiltrating endometriosis (study group)
  arm group label: B
  description: women without endometriosis
  intervention type: Other
  intervention name: Molecular markes of fibrosis of single types of endometriosis and their use in predicting disease severity
  description: 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.
  arm group label: A-DE
  arm group label: A-OE
  arm group label: A-PE
  specimen of eutopic endometrium and non-eutopic endometrial-like tissue
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: General University Hospital, Prague
  investigator full name: Zdenka Lisa
  investigator title: M.D.
  mesh term: Endometriosis
  mesh term: Fibrosis
  sharing ipd: No