<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/NCT03838055</url>
  </required_header>
  <id_info>
    <org_study_id>RegionSkaneKKLund3</org_study_id>
    <nct_id>NCT03838055</nct_id>
  </id_info>
  <brief_title>Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease</brief_title>
  <official_title>Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node&#xD;
      metastases in high risk and low risk endometrial cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consecutive patients with- and low risk endometrial cancer will be approached for eligibility&#xD;
      for inclusion in a study evaluating the detection rates of pelvic metastatic disease by&#xD;
      detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.&#xD;
&#xD;
      A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant&#xD;
      treatment.&#xD;
&#xD;
      The detection rate will be evaluated from a non-inferiority perspective against the expected&#xD;
      rate of nodal metastases based on detailed final histological data.&#xD;
&#xD;
      Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel&#xD;
      nodes), time for the intervention, and an objective evaluation of lymphatic complications&#xD;
      (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL&#xD;
      questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>
    <intervention_model_description>Prospective cohort study</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection rate of pelvic metastatic disease in endometrial cancer</measure>
    <time_frame>3 years from start inclusion with an interim analysis after 150 patients</time_frame>
    <description>The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes</measure>
    <time_frame>3 years from start inclusion</time_frame>
    <description>Exact measurements of time allocated for the SLN procedure as such.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of lymphedema after removal of sentinel lymph nodes</measure>
    <time_frame>4 years including at least one year follow up</time_frame>
    <description>Objective measurement lymphedema defined by of leg volume before and after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative adverse events associated with the study intervention</measure>
    <time_frame>3 years from start inclusion or after 150 patients if study stopped at interim analysis</time_frame>
    <description>Detailed registration of adverse events associated with the SLN procedure as such</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">362</enrollment>
  <condition>Sentinel Lymph Node</condition>
  <condition>Endometrial Cancer</condition>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>SLN only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pelvic SLN's defined by ICG injected cervically</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Injection of tracer ( ICG) and detection of sentinel lymph nodes</intervention_name>
    <description>Pelvic SLN's defined by ICG injected cervically</description>
    <arm_group_label>SLN only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of age 18 years and older at the time of informed consent.&#xD;
&#xD;
          -  Women with a pathologically proven endometrial carcinoma of any histologic subtype or&#xD;
             grade, clinically stage I-II planned for primary surgery&#xD;
&#xD;
          -  A uterine size allowing minimally invasive surgery&#xD;
&#xD;
          -  Women must be able to understand and sign an informed consent in Swedish language.&#xD;
&#xD;
          -  Absence of any exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non consenting patients&#xD;
&#xD;
          -  Ongoing pregnancy&#xD;
&#xD;
          -  Inability to understand written and/or oral study information&#xD;
&#xD;
          -  WHO performance status or conditions contraindicating adjuvant oncological treatment&#xD;
             (WHO III or more)&#xD;
&#xD;
          -  Previous lower limb lymphedema ( only for the lymphedema part of study)&#xD;
&#xD;
          -  Evidence of locally advanced disease or intraabdominal/distant metastases at&#xD;
             preoperative CT, MRI or ultrasonography.&#xD;
&#xD;
          -  Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons&#xD;
             discretion.&#xD;
&#xD;
          -  Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's&#xD;
             discretion&#xD;
&#xD;
          -  Allergy to Iodine&#xD;
&#xD;
          -  Patients with a known liver disease&#xD;
&#xD;
          -  Patients with a bleeding disorder or mandatory antithrombotic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Persson, Ass Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>RegionSkane, department of OB&amp;G, Skåne university hospital, Lund</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jan Persson, Ass prof</last_name>
    <phone>0046733522080</phone>
    <email>jan.persson@med.lu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michele Bollino, MD</last_name>
    <phone>0046723059274</phone>
    <email>michele.bollino@med.lu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Gynecology and Obstetrics</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>
    <mesh_term>Lymphedema</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03838055/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03838055
org study id: RegionSkaneKKLund3
nct id: NCT03838055
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node
      metastases in high risk and low risk endometrial cancer.
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility
      for inclusion in a study evaluating the detection rates of pelvic metastatic disease by
      detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.

      A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant
      treatment.

      The detection rate will be evaluated from a non-inferiority perspective against the expected
      rate of nodal metastases based on detailed final histological data.

      Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel
      nodes), time for the intervention, and an objective evaluation of lymphatic complications
      (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL
      questionnaire.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort study
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection rate of pelvic metastatic disease in endometrial cancer
time frame: 3 years from start inclusion with an interim analysis after 150 patients
description: The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
measure: Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
time frame: 3 years from start inclusion
description: Exact measurements of time allocated for the SLN procedure as such.
measure: Incidence of lymphedema after removal of sentinel lymph nodes
time frame: 4 years including at least one year follow up
description: Objective measurement lymphedema defined by of leg volume before and after surgery
measure: intraoperative adverse events associated with the study intervention
time frame: 3 years from start inclusion or after 150 patients if study stopped at interim analysis
description: Detailed registration of adverse events associated with the SLN procedure as such
arm group label: SLN only
arm group type: Experimental
description: Pelvic SLN's defined by ICG injected cervically
intervention type: Procedure
intervention name: Injection of tracer ( ICG) and detection of sentinel lymph nodes
description: Pelvic SLN's defined by ICG injected cervically
arm group label: SLN only
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jan Persson, Ass Prof
role: Principal Investigator
affiliation: RegionSkane, department of OB&G, Skåne university hospital, Lund
last name: Jan Persson, Ass prof
phone: 0046733522080
email: jan.persson@med.lu.se
last name: Michele Bollino, MD
phone: 0046723059274
email: michele.bollino@med.lu.se
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Lymphedema
provided document: 