<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/NCT01732432</url>
  </required_header>
  <id_info>
    <org_study_id>210/12</org_study_id>
    <nct_id>NCT01732432</nct_id>
  </id_info>
  <brief_title>Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC)</brief_title>
  <acronym>EAOC</acronym>
  <official_title>Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC) - Epidemiological and Molecular Pathological Aspects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a relationship exists between a previously&#xD;
      established diagnosis of endometriosis and the consecutive risk of developing a clear cell or&#xD;
      endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses&#xD;
      (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer&#xD;
      registry data will be assessed to investigate differences in survival of women with&#xD;
      endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without&#xD;
      previous diagnosis of endometriosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence and clinical outcome of endometriosis-associated ovarian carcinomas</measure>
    <time_frame>30 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Endometrioid Carcinoma</condition>
  <condition>Clear Cell Carcinoma</condition>
  <condition>Endometriosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        primary care hospital, university hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  endometrioid ovarian carcinoma&#xD;
&#xD;
          -  clear cell ovarian carcinoma&#xD;
&#xD;
          -  endometriosis, atypical endometriosis&#xD;
&#xD;
          -  borderline tumors with endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  undifferentiated carcinomas&#xD;
&#xD;
          -  germ cell tumors&#xD;
&#xD;
          -  sex cord-stromal tumors&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Obermann, MD, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Basel, University of Basel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ellen C Obermann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Pathology, University Hospital Basel, University of Basel</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</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>Carcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Adenomyoepithelioma</mesh_term>
    <mesh_term>Adenocarcinoma, Clear Cell</mesh_term>
    <mesh_term>Carcinoma, Endometrioid</mesh_term>
    <mesh_term>Endometriosis</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/NCT01732432
org study id: 210/12
nct id: NCT01732432
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether a relationship exists between a previously
      established diagnosis of endometriosis and the consecutive risk of developing a clear cell or
      endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses
      (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer
      registry data will be assessed to investigate differences in survival of women with
      endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without
      previous diagnosis of endometriosis.
time perspective: Retrospective
measure: incidence and clinical outcome of endometriosis-associated ovarian carcinomas
time frame: 30 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ellen Obermann, MD, Dr.
role: Principal Investigator
affiliation: University Hospital Basel, University of Basel
last name: Ellen C Obermann, MD
role: Principal Investigator
affiliation: Institute of Pathology, University Hospital Basel, University of Basel
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Adenomyoepithelioma
mesh term: Adenocarcinoma, Clear Cell
mesh term: Carcinoma, Endometrioid
mesh term: Endometriosis