<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/NCT04414683</url>
  </required_header>
  <id_info>
    <org_study_id>109058-E</org_study_id>
    <nct_id>NCT04414683</nct_id>
  </id_info>
  <brief_title>Factors Affecting the Prognosis of Early Ovarian Cancer</brief_title>
  <official_title>Factors Affecting the Prognosis of Early Ovarian Cancer</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>
      To elucidate factors affecting survival of early stage ovarian cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade,&#xD;
      intraoperative rupture, and laparoscopy vs. laparotomy, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 13, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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 of early ovarian cancer</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors affecting progression-free survival of early ovarian cancer</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Ovarian Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>staging surgery</intervention_name>
    <description>laparoscopic or laparotomic staging surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with early stage ovarian cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  early stage ovarian cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nil.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>ovarian cancer</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sheng-Mou Hsiao, MD</last_name>
    <phone>+886919302632</phone>
    <email>smhsiao2@gmail.com</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheng-Mou Hsiao, M.D.</last_name>
      <phone>+886-2-89667000</phone>
      <phone_ext>1818</phone_ext>
      <email>smhsiao2@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT04414683
org study id: 109058-E
nct id: NCT04414683
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To elucidate factors affecting survival of early stage ovarian cancer
To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade,
      intraoperative rupture, and laparoscopy vs. laparotomy, etc.
observational model: Cohort
time perspective: Retrospective
measure: Factors affecting overall survival of early ovarian cancer
time frame: 10 years
measure: Factors affecting progression-free survival of early ovarian cancer
time frame: 10 years
intervention type: Procedure
intervention name: staging surgery
description: laparoscopic or laparotomic staging surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: ovarian cancer
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sheng-Mou Hsiao, MD
phone: +886919302632
email: smhsiao2@gmail.com
facility: 
status: Recruiting
contact: 
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: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial