<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/NCT03024398</url>
  </required_header>
  <id_info>
    <org_study_id>6492</org_study_id>
    <nct_id>NCT03024398</nct_id>
  </id_info>
  <brief_title>Evaluation of the Fluorescent Green of Indocyanine in the Detection of Sentinel Lymph Node in Endometrial Cancer</brief_title>
  <acronym>Sentimetre</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Selective lymphadenectomy Sentinel (LSS). This technique is already well established in&#xD;
      breast cancer and melanoma and more recently in vulvar and cervical cancer.&#xD;
&#xD;
      Compared to lymphadenectomy, it has several theoretical advantages:&#xD;
&#xD;
        -  this is a sensitive technique with a detection rate of&gt; 90% and a false negative rate of&#xD;
           &lt;5%.&#xD;
&#xD;
        -  the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin&#xD;
           antibodies, serial sections) are more sensitive than the standard histological analysis&#xD;
           of lymphadenectomy, which allows an improvement in the detection of metastases&#xD;
           (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to&#xD;
           detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in&#xD;
           15% of intermediate-risk patients.&#xD;
&#xD;
        -  it avoids short-term and long-term operative and post-operative morbidity of&#xD;
           lymphadenectomy.&#xD;
&#xD;
      Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric&#xD;
      method coupled with the Technetium 99m isotopic method with an overall detection rate of 78%&#xD;
      [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an&#xD;
      overall detection rate of 94% and a bilateral detection rate of 80%.&#xD;
&#xD;
      It seemed useful to take stock of this technique using this new dye.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 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>Detection of sentinel node</measure>
    <time_frame>1 hour after surgery</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cancer of the Endometrium</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with confirmed biopsy endometrial cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient, without guardianship or curatorship.&#xD;
&#xD;
          -  patient with endometrial cancer confirmed by biopsy.&#xD;
&#xD;
          -  Invasive cancer stage FIGO I at intermediate risk and high risk and II according to&#xD;
             the FIGO classification.&#xD;
&#xD;
          -  need for surgical staging.&#xD;
&#xD;
          -  performing an endovaginal ultrasound or a pelvic MRI in preoperative, if&#xD;
             contraindication to MRI, performing a CT scan.&#xD;
&#xD;
          -  subject affiliated to a social health insurance scheme.&#xD;
&#xD;
          -  speaking and reading French.&#xD;
&#xD;
          -  subject having dated and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy in progress.&#xD;
&#xD;
          -  FIGO III and IV stage diagnosed preoperatively or intraoperatively.&#xD;
&#xD;
          -  Cure or pre-surgery that may alter the uterine lymphatic drainage (conization,&#xD;
             myomectomy).&#xD;
&#xD;
          -  MRI or CT scan of suspected lymph nodes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cherif Youssef AKLADIOS, MD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cherif Youssef AKLADIOS, MD</last_name>
    <phone>33 3 88 12 83 35</phone>
    <email>cherif.youssef.azer@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean-Jacques BALDAUF, MD, PhD</last_name>
    <phone>33 3 88 12 83 35</phone>
    <email>Jean-Jacques.Baldauf@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de gynécologie-obstétrique - Hôpital de Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cherif Youssef AKLADIOS, MD</last_name>
      <phone>33 3 88 12 83 35</phone>
      <email>cherif.youssef.azer@chru-strasbourg.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jean-Jacques BALDAUF, MD, PhD</last_name>
      <phone>33 3 88 12 83 35</phone>
      <email>Jean-Jacques.Baldauf@chru-strasbourg.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 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>Endometrial 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/NCT03024398
org study id: 6492
nct id: NCT03024398
lead sponsor: 
has dmc: No
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in
      breast cancer and melanoma and more recently in vulvar and cervical cancer.

      Compared to lymphadenectomy, it has several theoretical advantages:

        -  this is a sensitive technique with a detection rate of> 90% and a false negative rate of
           <5%.

        -  the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin
           antibodies, serial sections) are more sensitive than the standard histological analysis
           of lymphadenectomy, which allows an improvement in the detection of metastases
           (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was possible to
           detect lymph node metastases in 11% of patients with low-risk endometrial cancer and in
           15% of intermediate-risk patients.

        -  it avoids short-term and long-term operative and post-operative morbidity of
           lymphadenectomy.

      Early studies of LSS in endometrial cancer demonstrated superior efficacy of the colorimetric
      method coupled with the Technetium 99m isotopic method with an overall detection rate of 78%
      [95% CI: 73-84]. The fluorescent green of indocyanine appears to give better results with an
      overall detection rate of 94% and a bilateral detection rate of 80%.

      It seemed useful to take stock of this technique using this new dye.
observational model: Cohort
time perspective: Prospective
measure: Detection of sentinel node
time frame: 1 hour after surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cherif Youssef AKLADIOS, MD
role: Study Director
affiliation: University Hospital, Strasbourg, France
last name: Cherif Youssef AKLADIOS, MD
phone: 33 3 88 12 83 35
email: cherif.youssef.azer@chru-strasbourg.fr
last name: Jean-Jacques BALDAUF, MD, PhD
phone: 33 3 88 12 83 35
email: Jean-Jacques.Baldauf@chru-strasbourg.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
sharing ipd: No