<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/NCT03749707</url>
  </required_header>
  <id_info>
    <org_study_id>SLN2018</org_study_id>
    <nct_id>NCT03749707</nct_id>
  </id_info>
  <brief_title>HPV in Sentinel Lymph Nodes</brief_title>
  <official_title>HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      This study examines sentinel lymph node tissue from early stage cervical cancer patients&#xD;
      treated with radical hysterectomy and removal of pelvic sentinel lymph nodes (SLN). SLNs are&#xD;
      tested for the presence of human papilloma virus (HPV), and results are compared to the&#xD;
      HPV-type found in the patients cervical tissue.&#xD;
&#xD;
      We hereby examine whether pathologic status of SLNs in patients with early-stage cervical&#xD;
      cancer correlates to the HPV status in the SLNs. By means of an up to 5-years follow-up&#xD;
      period, we furthermore examine whether cervical cancer recurrence correlates to the&#xD;
      histopathologic status of the SLNs and/or the SLN HPV status. This will contribute to the&#xD;
      clarification on whether HPV status of the SLNs plays a crucial role for predicting LN&#xD;
      metastasis of cervical cancer and also, whether the HPV status in SLNs may have a clinical&#xD;
      value as a prognostic factor for disease recurrence in cervical cancer patients and perhaps&#xD;
      even a better clinical value than SLN mapping.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to examine whether the pathologic status of SLNs in patients with&#xD;
      early-stage cervical cancer correlates to the HPV status in the SLNs and also, whether&#xD;
      cervical cancer recurrence correlates to the histopathologic status of the SLNs and/or the&#xD;
      SLN HPV status.&#xD;
&#xD;
      In Denmark, staging and treatment of cervical cancer are performed according to the&#xD;
      recommendations of the International Federation of Gynecology and Obstetrics (FIGO). Cervical&#xD;
      cancer is the only gynecological cancer that is clinically based on tumor size, vaginal or&#xD;
      parametrial involvement, bladder/rectum extension and distant metastases. It requires&#xD;
      examination under anesthesia and imaging, which in Denmark includes positron emission&#xD;
      computed tomography (PET-CT) to detect pathological lymph nodes (LNs) and to accurately&#xD;
      delineate the extent of the disease and magnetic resonance imaging (MRI) to determine tumor&#xD;
      size, degree of stromal penetration, parametrial involvement, vaginal and corpus extension.&#xD;
      Tumor risk assessment includes tumor size, stage, depth of tumor invasion, LN status,&#xD;
      lymphovascular space invasion (LVSI) and histological subtype, of which LN status and number&#xD;
      of LNs involved are the most important prognostic factors. In Denmark, patients at FIGO&#xD;
      stages 1B1 to 2A undergo radical hysterectomy and radical pelvic lymphadenectomy (PL), and&#xD;
      they are offered adjuvant oncological treatment with radiotherapy and concomitant&#xD;
      chemotherapy if specific risk factors are present. A national protocolled study on the&#xD;
      implementation of SLN mapping in women with early-stage cervical cancer is currently being&#xD;
      conducted in Denmark at Rigshospitalet, Odense University Hospital and Aarhus University&#xD;
      Hospital (The Sentirec study). In this study, we want to examine the remains from these&#xD;
      analyzed SLNs. According to the Sentirec protocol, SLNs are examined by means of&#xD;
      ultrastaging, which entails cutting the SLNs in more sections and all levels of the LN and&#xD;
      examining these levels histologically by an experienced pathologist. In this study, we&#xD;
      examine the remains from the SLNs; that is the sections between the tissue used for SLN&#xD;
      mapping. These sections are analyzed for HPV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 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>Early-stage cervical cancer patients treated with radical hysterectomy and removal of SLNs.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HPV</measure>
    <time_frame>0 hours post-operation</time_frame>
    <description>The presence of HPV in SLNs</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Sentinel Lymph Node</condition>
  <condition>HPV-Related Cervical Carcinoma</condition>
  <arm_group>
    <arm_group_label>SLNs from early-stage cervical cancer patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HPV analysis</intervention_name>
    <description>HPV analysis of SLNs</description>
    <arm_group_label>SLNs from early-stage cervical cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman &gt; 18 years of age diagnosed with cervical cancer and admitted for surgery with&#xD;
             radical hysterectomy and removal of SLNs between October 2018 and June 2022.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Woman &lt; 18 years&#xD;
&#xD;
          -  Women with late-stage cervical cancer, who are treated with radio- and chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Early-stage cervical cancer patients admitted for surgery with radical hysterectomy and removal of SLNs.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sara Bønløkke Simonsen</last_name>
    <phone>0045 53372162</phone>
    <email>sarasim@clin.au.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Bønløkke Simonsen</last_name>
      <phone>0045 53372162</phone>
      <email>sarasim@clin.au.dk</email>
    </contact>
    <contact_backup>
      <last_name>Katrine Fuglsang, PhD</last_name>
      <phone>0045 23390224</phone>
      <email>katrfugl@rm.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HPV</keyword>
  <keyword>Cervical cancer</keyword>
  <keyword>SLN</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03749707
org study id: SLN2018
nct id: NCT03749707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines sentinel lymph node tissue from early stage cervical cancer patients
      treated with radical hysterectomy and removal of pelvic sentinel lymph nodes (SLN). SLNs are
      tested for the presence of human papilloma virus (HPV), and results are compared to the
      HPV-type found in the patients cervical tissue.

      We hereby examine whether pathologic status of SLNs in patients with early-stage cervical
      cancer correlates to the HPV status in the SLNs. By means of an up to 5-years follow-up
      period, we furthermore examine whether cervical cancer recurrence correlates to the
      histopathologic status of the SLNs and/or the SLN HPV status. This will contribute to the
      clarification on whether HPV status of the SLNs plays a crucial role for predicting LN
      metastasis of cervical cancer and also, whether the HPV status in SLNs may have a clinical
      value as a prognostic factor for disease recurrence in cervical cancer patients and perhaps
      even a better clinical value than SLN mapping.
The aim of the study is to examine whether the pathologic status of SLNs in patients with
      early-stage cervical cancer correlates to the HPV status in the SLNs and also, whether
      cervical cancer recurrence correlates to the histopathologic status of the SLNs and/or the
      SLN HPV status.

      In Denmark, staging and treatment of cervical cancer are performed according to the
      recommendations of the International Federation of Gynecology and Obstetrics (FIGO). Cervical
      cancer is the only gynecological cancer that is clinically based on tumor size, vaginal or
      parametrial involvement, bladder/rectum extension and distant metastases. It requires
      examination under anesthesia and imaging, which in Denmark includes positron emission
      computed tomography (PET-CT) to detect pathological lymph nodes (LNs) and to accurately
      delineate the extent of the disease and magnetic resonance imaging (MRI) to determine tumor
      size, degree of stromal penetration, parametrial involvement, vaginal and corpus extension.
      Tumor risk assessment includes tumor size, stage, depth of tumor invasion, LN status,
      lymphovascular space invasion (LVSI) and histological subtype, of which LN status and number
      of LNs involved are the most important prognostic factors. In Denmark, patients at FIGO
      stages 1B1 to 2A undergo radical hysterectomy and radical pelvic lymphadenectomy (PL), and
      they are offered adjuvant oncological treatment with radiotherapy and concomitant
      chemotherapy if specific risk factors are present. A national protocolled study on the
      implementation of SLN mapping in women with early-stage cervical cancer is currently being
      conducted in Denmark at Rigshospitalet, Odense University Hospital and Aarhus University
      Hospital (The Sentirec study). In this study, we want to examine the remains from these
      analyzed SLNs. According to the Sentirec protocol, SLNs are examined by means of
      ultrastaging, which entails cutting the SLNs in more sections and all levels of the LN and
      examining these levels histologically by an experienced pathologist. In this study, we
      examine the remains from the SLNs; that is the sections between the tissue used for SLN
      mapping. These sections are analyzed for HPV.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Early-stage cervical cancer patients treated with radical hysterectomy and removal of SLNs.
primary purpose: Prevention
masking: None (Open Label)
measure: HPV
time frame: 0 hours post-operation
description: The presence of HPV in SLNs
arm group label: SLNs from early-stage cervical cancer patients
arm group type: Other
description: Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.
intervention type: Diagnostic Test
intervention name: HPV analysis
description: HPV analysis of SLNs
arm group label: SLNs from early-stage cervical cancer patients
criteria: 
gender: Female
gender based: Yes
gender description: Early-stage cervical cancer patients admitted for surgery with radical hysterectomy and removal of SLNs.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Bønløkke Simonsen
phone: 0045 53372162
email: sarasim@clin.au.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms