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/NCT06017531</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A</org_study_id>
      <nct_id>NCT06017531</nct_id>
    </id_info>
    <brief_title>Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)</brief_title>
    <official_title>Ultrasonographic Characterization of Parametrial Lesions in Deep Endometriosis: A Diagnostic-Accuracy Study (ULTRA-PARAMETRENDO III)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS Sacro Cuore Don Calabria di Negrar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS Sacro Cuore Don Calabria di Negrar</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center, prospective diagnostic-accuracy study. All women who will undergo&#xD;
        surgery for DE after preoperative ultrasound for six consecutive months will be included.&#xD;
        Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients&#xD;
        will be collected. Surgical and pathological data will be analyzed to confirm the presence of&#xD;
        parametrial DE.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective diagnostic-accuracy study. All women who will undergo&#xD;
        surgery for DE after preoperative ultrasound for six consecutive months will be included.&#xD;
        Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients&#xD;
        will be collected. Surgical and pathological data will be analyzed to confirm the presence of&#xD;
        parametrial DE.&#xD;
  &#xD;
        All the study procedures are done according to our clinical practice. Demographic and&#xD;
        ultrasonographic data will be collected from the preoperative evaluation, which is routinely&#xD;
        done at our institution by four ultrasonographic expert in diagnosing deep endometriosis.&#xD;
        Surgical and pathological data will be collected during surgical procedures and hospital&#xD;
        stay.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 28, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic accuracy</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sensitivity</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>positive predictive value</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>negative predictive value</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Positive likelihood ratio</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Negative likelihood ratio</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Characteristics of parametrial DE</measure>
      <time_frame>Preoperative exam</time_frame>
      <description>Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for distinguishing the intraoperative presence of parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium) with surgical and/or histological confirmation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infiltration of parametrial DE nodules</measure>
      <time_frame>Preoperative exam, surgical and/or histological confirmation</time_frame>
      <description>Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative infiltration of parametrial DE nodules in other pelvic structures (i.e. rectosigmoid, uterosacral ligaments) with surgical and/or histological confirmation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Other DE nodules and indirect DE signs</measure>
      <time_frame>Preoperative exam</time_frame>
      <description>Prevalence of other DE nodules and indirect DE signs in patients in the case of evidence of parametrial DE at preoperative ultrasound</description>
    </secondary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Endometriosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All women who will undergo surgery for DE after preoperative ultrasound for six consecutive&#xD;
          months will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  clinical suspicion of DE, for which a preoperative transvaginal ultrasonographic&#xD;
               assessment and laparoscopic surgical approach will be indicated;&#xD;
  &#xD;
            -  age &gt; or equal to 18 years&#xD;
  &#xD;
            -  informed consent for the participation in the study and for personal data treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous surgical diagnosis of parametrial DE;&#xD;
  &#xD;
            -  previous radiological diagnosis of parametrial DE including techniques used to&#xD;
               diagnose DE (such as magnetic resonance [MRI], computed tomography-based virtual&#xD;
               colonoscopy [CTC] or double-contrast barium enema);&#xD;
  &#xD;
            -  previous bilateral ovariectomy.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>IRCCS Sacro Cuore Don Calabria di Negrar</name>
        <address>
          <city>Negrar</city>
          <state>Verona</state>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marcello Ceccaroni, Doctor</last_name>
        <email>marcello.ceccaroni@sacrocuore.it</email>
      </contact>
      <contact_backup>
        <phone>0456013111</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometriosis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017531
  org study id: 2023-A
  nct id: NCT06017531
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, prospective diagnostic-accuracy study. All women who will undergo
        surgery for DE after preoperative ultrasound for six consecutive months will be included.
        Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients
        will be collected. Surgical and pathological data will be analyzed to confirm the presence of
        parametrial DE.
  This is a single-center, prospective diagnostic-accuracy study. All women who will undergo
        surgery for DE after preoperative ultrasound for six consecutive months will be included.
        Anamnestic and preoperative (physical objective and ultrasonographic) data of these patients
        will be collected. Surgical and pathological data will be analyzed to confirm the presence of
        parametrial DE.
  
        All the study procedures are done according to our clinical practice. Demographic and
        ultrasonographic data will be collected from the preoperative evaluation, which is routinely
        done at our institution by four ultrasonographic expert in diagnosing deep endometriosis.
        Surgical and pathological data will be collected during surgical procedures and hospital
        stay.
  observational model: Cohort
  time perspective: Prospective
  measure: Diagnostic accuracy
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Diagnostic accuracy of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: Sensitivity
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Sensitivity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: Specificity
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Specificity of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: positive predictive value
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: negative predictive value
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: Positive likelihood ratio
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Positive likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: Negative likelihood ratio
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative presence of parametrial DE with surgical and/or histological confirmation.
  measure: Characteristics of parametrial DE
  time frame: Preoperative exam
  description: Characteristics of parametrial DE (parametrial localizations, size, margins, echogenicity) evaluated at preoperative ultrasound
  measure: Parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium)
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for distinguishing the intraoperative presence of parametrial DE in the three different parametrial areas (posterior, lateral, and anterior parametrium) with surgical and/or histological confirmation.
  measure: Infiltration of parametrial DE nodules
  time frame: Preoperative exam, surgical and/or histological confirmation
  description: Diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of transvaginal ultrasound for detecting the intraoperative infiltration of parametrial DE nodules in other pelvic structures (i.e. rectosigmoid, uterosacral ligaments) with surgical and/or histological confirmation
  measure: Other DE nodules and indirect DE signs
  time frame: Preoperative exam
  description: Prevalence of other DE nodules and indirect DE signs in patients in the case of evidence of parametrial DE at preoperative ultrasound
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Endometriosis