<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/NCT03804463</url>
  </required_header>
  <id_info>
    <org_study_id>2017PS017K</org_study_id>
    <nct_id>NCT03804463</nct_id>
  </id_info>
  <brief_title>The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer</brief_title>
  <official_title>The Randomized Multicentic Prospective Controlled Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Min Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shengjing Hospital</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>
      Through multicenter, prospective, randomized, controlled clinical studies comparing different&#xD;
      treatment options (fertility-sparing surgery and ovarian preservation surgery and radical&#xD;
      surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best&#xD;
      strategies and risks for the treatment of early endometrial cancer, and promotion and&#xD;
      application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients eligible for enrollment are selected and divided into three groups randomly,&#xD;
      including fertility group,ovarian preservation group and endometrial cancer radical surgery&#xD;
      group. Take interventions including fertility preservation surgery,ovarian preservation&#xD;
      surgery and endometrial cancer radical surgery for patients in different groups respectively.&#xD;
      Compare therapeutic efficacy, safety and quality of life of patients to evaluate three&#xD;
      treatment and explore the best treatment for clinical application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total survival Time</measure>
    <time_frame>6 months</time_frame>
    <description>calculate the time from patients enter the group to death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of Ovarian volume</measure>
    <time_frame>6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>measure the ovarian volume dynamically by ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change of endocrine function evaluation</measure>
    <time_frame>6 months, 1 year, 2 years, 3 years, 4 years, 5 years</time_frame>
    <description>measure the endocrine function(hormone level) dynamically by blood detection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>6 months</time_frame>
    <description>calculate the time from patients enter the group to tumor progression</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>radical surgery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endometrial cancer radical surgery to be administered in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fertility preservation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fertility-sparing surgery to be administered in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ovarian preservation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ovarian preservation surgery to be administered in this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endometrial cancer radical surgery</intervention_name>
    <description>Take hysterectomy and bilateral adnexectomy.</description>
    <arm_group_label>radical surgery group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fertility-sparing surgery</intervention_name>
    <description>Take endometrectomy , preserve uterus and bilateral ovaries.</description>
    <arm_group_label>fertility preservation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ovarian preservation surgery</intervention_name>
    <description>Take hysterectomy,preserve bilateral ovaries.</description>
    <arm_group_label>ovarian preservation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Premenopausal women, age ≤ 50 years&#xD;
&#xD;
          2. Surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma&#xD;
             G1/G2 (including well-differentiated, high-medium and middle-differentiation);&#xD;
&#xD;
          3. Clinical consideration of IA (&lt;1/2 muscle infiltration);&#xD;
&#xD;
          4. First-time treatment&#xD;
&#xD;
          5. The subject (or his legal representative) must understand the nature of the study and&#xD;
             sign an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. At the same time participate in other clinical trials;&#xD;
&#xD;
          2. Can not tolerate surgery;&#xD;
&#xD;
          3. Ovarian suspicious metastasis;&#xD;
&#xD;
          4. Have a family history of ovarian cancer;&#xD;
&#xD;
          5. Incorporate other malignant tumors;&#xD;
&#xD;
          6. Preoperative CA125 abnormal persons&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Wang, PHD.</last_name>
    <role>Study Director</role>
    <affiliation>Shengjing Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Min Wang, PHD.</last_name>
    <phone>18940251222</phone>
    <email>wm21st@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>YiSi Liu</last_name>
    <phone>18640138683</phone>
    <email>liuyisi91@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shengjing Hospitaol of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Min Wang, PHD</last_name>
      <phone>18940251222</phone>
      <email>wm21st@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>June 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shengjing Hospital</investigator_affiliation>
    <investigator_full_name>Min Wang</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Preservation of fertility surger</keyword>
  <keyword>ovarian preservation</keyword>
  <keyword>endometrial cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03804463
org study id: 2017PS017K
nct id: NCT03804463
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Through multicenter, prospective, randomized, controlled clinical studies comparing different
      treatment options (fertility-sparing surgery and ovarian preservation surgery and radical
      surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best
      strategies and risks for the treatment of early endometrial cancer, and promotion and
      application.
Patients eligible for enrollment are selected and divided into three groups randomly,
      including fertility group,ovarian preservation group and endometrial cancer radical surgery
      group. Take interventions including fertility preservation surgery,ovarian preservation
      surgery and endometrial cancer radical surgery for patients in different groups respectively.
      Compare therapeutic efficacy, safety and quality of life of patients to evaluate three
      treatment and explore the best treatment for clinical application.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total survival Time
time frame: 6 months
description: calculate the time from patients enter the group to death
measure: the change of Ovarian volume
time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: measure the ovarian volume dynamically by ultrasonography
measure: the change of endocrine function evaluation
time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
description: measure the endocrine function(hormone level) dynamically by blood detection
measure: Progression Free Survival
time frame: 6 months
description: calculate the time from patients enter the group to tumor progression
arm group label: radical surgery group
arm group type: Experimental
description: Endometrial cancer radical surgery to be administered in this arm.
arm group label: fertility preservation group
arm group type: Experimental
description: Fertility-sparing surgery to be administered in this arm.
arm group label: ovarian preservation group
arm group type: Experimental
description: Ovarian preservation surgery to be administered in this arm.
intervention type: Procedure
intervention name: endometrial cancer radical surgery
description: Take hysterectomy and bilateral adnexectomy.
arm group label: radical surgery group
intervention type: Procedure
intervention name: fertility-sparing surgery
description: Take endometrectomy , preserve uterus and bilateral ovaries.
arm group label: fertility preservation group
intervention type: Procedure
intervention name: ovarian preservation surgery
description: Take hysterectomy,preserve bilateral ovaries.
arm group label: ovarian preservation group
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Min Wang, PHD.
role: Study Director
affiliation: Shengjing Hospital
last name: Min Wang, PHD.
phone: 18940251222
email: wm21st@126.com
last name: YiSi Liu
phone: 18640138683
email: liuyisi91@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shengjing Hospital
investigator full name: Min Wang
investigator title: Director
mesh term: Endometrial Neoplasms
sharing ipd: No