<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/NCT02988765</url>
  </required_header>
  <id_info>
    <org_study_id>Morpho-Node</org_study_id>
    <nct_id>NCT02988765</nct_id>
  </id_info>
  <brief_title>Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma</brief_title>
  <acronym>Morpho-Node</acronym>
  <official_title>Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in&#xD;
      which the preoperative evaluation is critical to address surgery between sentinel node biopsy&#xD;
      or radical groin lymphadenectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment,&#xD;
      the investigators decided to better investigate the role of ultrasound in groin nodes&#xD;
      evaluation through the study 10 sonographic features of suspicion for nodal involvement:&#xD;
&#xD;
        -  globular shape (loss of the normal elliptical form)&#xD;
&#xD;
        -  long/short axis ratio&#xD;
&#xD;
        -  cortical/medulla ratio&#xD;
&#xD;
        -  cortical focal bulging or thickening&#xD;
&#xD;
        -  hilum anomalies&#xD;
&#xD;
        -  inhomogeneous echostructure&#xD;
&#xD;
        -  intranodal deposits&#xD;
&#xD;
        -  extracapsular spread&#xD;
&#xD;
        -  grouping&#xD;
&#xD;
        -  vascularization&#xD;
&#xD;
      The standard of comparison is histopathology.&#xD;
&#xD;
      The prospectively evaluation of these parameters will be obtained on the enrolled patients.&#xD;
&#xD;
      The investigators also provided the retrospective review - by specialized staff - of&#xD;
      ultrasound images collected in archives associated with information relating to the&#xD;
      cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who&#xD;
      underwent surgical treatment in the last five years at the study center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Vulvar Cancer</condition>
  <arm_group>
    <arm_group_label>Invasive vulvar cancer (IVC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vulvar carcinoma (stromal infiltration &gt; 1 mm)&#xD;
Histotypes different from squamous cells carcinomas are included</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Groin ultrasound +/- fine needle aspiration</intervention_name>
    <description>Preoperative ultrasound morphometry (USM) of the inguino-femoral lymph nodes (IFLN).&#xD;
The FNAC and/or FNAB is performed in case of suspicious nodes, if at least one of the selected criteria is relieved during ultrasound</description>
    <arm_group_label>Invasive vulvar cancer (IVC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Invasive vulvar cancer (all infiltrating histotypes)&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient unable to follow the study procedures&#xD;
&#xD;
          -  patient with major depressive disorder&#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>Division of Gynecologic Oncology/Fondazione Policlinico Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giorgia Garganese, MD</last_name>
      <phone>00390630158545</phone>
      <email>ggarganese@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Simona M Fragomeni, MD</last_name>
      <phone>00390630158545</phone>
      <email>simona.fragomeni@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Giovanni Scambia, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giorgia Garganese, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simona Fragomeni, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Prof. Giovanni Scambia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>vulvar cancer</keyword>
  <keyword>inguinal lymph node</keyword>
  <keyword>lymph node status</keyword>
  <keyword>cytology</keyword>
  <keyword>core biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvar Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02988765
org study id: Morpho-Node
nct id: NCT02988765
lead sponsor: 
has dmc: No
Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in
      which the preoperative evaluation is critical to address surgery between sentinel node biopsy
      or radical groin lymphadenectomy.
In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment,
      the investigators decided to better investigate the role of ultrasound in groin nodes
      evaluation through the study 10 sonographic features of suspicion for nodal involvement:

        -  globular shape (loss of the normal elliptical form)

        -  long/short axis ratio

        -  cortical/medulla ratio

        -  cortical focal bulging or thickening

        -  hilum anomalies

        -  inhomogeneous echostructure

        -  intranodal deposits

        -  extracapsular spread

        -  grouping

        -  vascularization

      The standard of comparison is histopathology.

      The prospectively evaluation of these parameters will be obtained on the enrolled patients.

      The investigators also provided the retrospective review - by specialized staff - of
      ultrasound images collected in archives associated with information relating to the
      cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who
      underwent surgical treatment in the last five years at the study center.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
time frame: within the first 30 days after surgery
measure: Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status
time frame: within the first 30 days after surgery
arm group label: Invasive vulvar cancer (IVC)
arm group type: Experimental
description: Vulvar carcinoma (stromal infiltration > 1 mm)
Histotypes different from squamous cells carcinomas are included
intervention type: Procedure
intervention name: Groin ultrasound +/- fine needle aspiration
description: Preoperative ultrasound morphometry (USM) of the inguino-femoral lymph nodes (IFLN).
The FNAC and/or FNAB is performed in case of suspicious nodes, if at least one of the selected criteria is relieved during ultrasound
arm group label: Invasive vulvar cancer (IVC)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Prof. Giovanni Scambia
investigator title: Professor
mesh term: Vulvar Neoplasms
sharing ipd: No