<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/NCT04412902</url>
  </required_header>
  <id_info>
    <org_study_id>109053-E</org_study_id>
    <nct_id>NCT04412902</nct_id>
  </id_info>
  <brief_title>Predictors of Recurrence for High Risk Endometrial Cancer Patients</brief_title>
  <official_title>Predictors of Recurrence for High Risk Endometrial Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</source>
  <oversight_info>
    <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 will analyze whether there is any difference in recurrence and survival rates&#xD;
      among the patients who received different adjuvant therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of endometrial cancer is gradually increasing nowaday. The postoperative&#xD;
      treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of&#xD;
      high-risk endometrial cancer is high.The investigators retrospective study will analyze the&#xD;
      factors associated with recurrence of endometrial cancer, especially for different adjuvant&#xD;
      therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2020</start_date>
  <completion_date type="Actual">November 25, 2020</completion_date>
  <primary_completion_date type="Actual">October 25, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Factors affecting overall survival</measure>
    <time_frame>10 years</time_frame>
    <description>Factors affecting overall survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors affecting progression-free survival</measure>
    <time_frame>10 years</time_frame>
    <description>Factors affecting progression-free survival</description>
  </secondary_outcome>
  <enrollment type="Actual">92</enrollment>
  <condition>High-risk Endometrial Cancer</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>adjuvant therapy</intervention_name>
    <description>Adjuvant chemotherapy and/or radiotherapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All high risk endometrial cancer patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with high risk stage I endometrial cancer and all patients with stage II&#xD;
             and stage III endometrial cancer and who underwent therapy in Far Eastern Memorial&#xD;
             Hospital from 2009/01/01~2019/09/17.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with stage I endometrial cancer do not have high risk factors.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>high risk endometrial cancer patients</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief of Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Recurrence</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/NCT04412902
org study id: 109053-E
nct id: NCT04412902
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will analyze whether there is any difference in recurrence and survival rates
      among the patients who received different adjuvant therapies.
The incidence of endometrial cancer is gradually increasing nowaday. The postoperative
      treatment of high-risk endometrial cancer is also inconsistent. Besides, the recurrence of
      high-risk endometrial cancer is high.The investigators retrospective study will analyze the
      factors associated with recurrence of endometrial cancer, especially for different adjuvant
      therapies.
observational model: Cohort
time perspective: Retrospective
measure: Factors affecting overall survival
time frame: 10 years
description: Factors affecting overall survival
measure: Factors affecting progression-free survival
time frame: 10 years
description: Factors affecting progression-free survival
intervention type: Drug
intervention name: adjuvant therapy
description: Adjuvant chemotherapy and/or radiotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: high risk endometrial cancer patients
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief of Department of Obstetrics & Gynecology
mesh term: Endometrial Neoplasms
mesh term: Recurrence