<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/NCT03289468</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF-CRF-2016T-14</org_study_id>
    <nct_id>NCT03289468</nct_id>
  </id_info>
  <brief_title>Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases</brief_title>
  <official_title>Study of Diagnosis of Color Power Doppler Combined Minimally Invasive Sampling for Endometrial Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</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>
      The postmenopausal women with vaginal bleeding were selected in this cross-sectional study.&#xD;
      The basic characteristics information and endometrial blood flow energy index of endometrium&#xD;
      were detected by color power Doppler ultrasound, and the energy histogram of endometrium was&#xD;
      obtained. The specimen of uterine cytology and endometrial tissue were obtained through&#xD;
      minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical&#xD;
      data were used to detect endometrial and precancerous lesions to observe the endpoint, and to&#xD;
      provide the energy histogram model of the early warning endothelial diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The postmenopausal women with vaginal bleeding are selected in this cross-sectional study.&#xD;
      The uterine bleeding in patients with blood system diseases, reproductive organ outside the&#xD;
      uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided&#xD;
      into two groups(patients with endometrial benign diseases and patients with endometrial&#xD;
      cancer and precancerous diseases) according to endometrial cytological and histological&#xD;
      pathology. The endometrial thickness, basic characteristics information and endometrial blood&#xD;
      flow energy index, endometrial vascularization index, blood flow index are detected by color&#xD;
      power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE&#xD;
      Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and&#xD;
      endometrial tissue are obtained through minimally invasive endometrium sampler, which were&#xD;
      diagnosed by pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The endometrial vascularization index</measure>
    <time_frame>From March 2019 to December 2019</time_frame>
    <description>The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ultrasonography of endometrium</measure>
    <time_frame>From March 2019 to December 2019</time_frame>
    <description>The ultrasonography of endometrium included shape, boundary and echo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The endometrial thickness</measure>
    <time_frame>From March 2019 to December 2019</time_frame>
    <description>The endometrial thickness in centimeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The blood flow index of endometrium</measure>
    <time_frame>From March 2019 to December 2019</time_frame>
    <description>The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Endometrial Diseases</condition>
  <arm_group>
    <arm_group_label>Group1</arm_group_label>
    <description>Endometrial Benign Disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group2</arm_group_label>
    <description>Endometrial Cancer and Precancerous Lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler</intervention_name>
    <description>The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.</description>
    <arm_group_label>Group1</arm_group_label>
    <arm_group_label>Group2</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      FirstXianJiaotongU&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Postmenopausal women with vaginal bleeding&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal women with vaginal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vaginal bleeding caused by hematological system diseases or genitals outside the&#xD;
             uterus&#xD;
&#xD;
          -  Uterine bleeding caused by other organ cancers metastasize to the uterus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Xiaofeng YANG, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>The First Affiliated Hospital of Xian Jiaotong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaofeng YANG, Doctor</last_name>
    <phone>0086-18602900810</phone>
    <email>yxf73@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaofeng YANG</last_name>
      <email>yxf73@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>August 4, 2019</last_update_submitted>
  <last_update_submitted_qc>August 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</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>Uterine Diseases</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/NCT03289468
org study id: XJTU1AF-CRF-2016T-14
nct id: NCT03289468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The postmenopausal women with vaginal bleeding were selected in this cross-sectional study.
      The basic characteristics information and endometrial blood flow energy index of endometrium
      were detected by color power Doppler ultrasound, and the energy histogram of endometrium was
      obtained. The specimen of uterine cytology and endometrial tissue were obtained through
      minimally invasive endometrium sampler, which were diagnosed by pathology. The statistical
      data were used to detect endometrial and precancerous lesions to observe the endpoint, and to
      provide the energy histogram model of the early warning endothelial diseases.
The postmenopausal women with vaginal bleeding are selected in this cross-sectional study.
      The uterine bleeding in patients with blood system diseases, reproductive organ outside the
      uterus, other organs cancer metastasis to the uterus are excluded. The objects are divided
      into two groups(patients with endometrial benign diseases and patients with endometrial
      cancer and precancerous diseases) according to endometrial cytological and histological
      pathology. The endometrial thickness, basic characteristics information and endometrial blood
      flow energy index, endometrial vascularization index, blood flow index are detected by color
      power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE
      Medical Systems, USA) ultrasound system. Moreover,The specimen of uterine cytology and
      endometrial tissue are obtained through minimally invasive endometrium sampler, which were
      diagnosed by pathology.
observational model: Other
time perspective: Cross-Sectional
measure: The endometrial vascularization index
time frame: From March 2019 to December 2019
description: The endometrial vascularization index include vascularization index(VI), flow index (FI) and vascularization flow index (VFI).
measure: The ultrasonography of endometrium
time frame: From March 2019 to December 2019
description: The ultrasonography of endometrium included shape, boundary and echo.
measure: The endometrial thickness
time frame: From March 2019 to December 2019
description: The endometrial thickness in centimeter.
measure: The blood flow index of endometrium
time frame: From March 2019 to December 2019
description: The blood flow index include peak systolic velocity(PSV),cm/s, end diastolic velocity(EDV) ,cm/s, mean flow velocity(MnV) ,cm/s, pulsatility index(PI), resistance index(RI).
arm group label: Group1
description: Endometrial Benign Disease
arm group label: Group2
description: Endometrial Cancer and Precancerous Lesions
intervention type: Diagnostic Test
intervention name: Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler
description: The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.
arm group label: Group1
arm group label: Group2
FirstXianJiaotongU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 80 Years
last name: Xiaofeng YANG, Doctor
role: Study Director
affiliation: The First Affiliated Hospital of Xian Jiaotong University
last name: Xiaofeng YANG, Doctor
phone: 0086-18602900810
email: yxf73@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Uterine Diseases
sharing ipd: No