<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/NCT03785574</url>
  </required_header>
  <id_info>
    <org_study_id>CSEM 012</org_study_id>
    <nct_id>NCT03785574</nct_id>
  </id_info>
  <brief_title>Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule</brief_title>
  <official_title>Study of Different Therapeutic Strategies in Hydatidiform Mole With Lung Nodule，A Prospective Multicentre Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Women's Hospital School Of Medicine Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Women's Hospital School Of Medicine Zhejiang University</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>
      The purpose of present study is to provide clinical evidences for the appropriate management&#xD;
      of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm&#xD;
      will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up&#xD;
      until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal&#xD;
      spontaneously (B2). Lung nodule &lt;1.0cm will directly treated as group C&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A.&#xD;
      treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic&#xD;
      criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical&#xD;
      characteristics of patients were compared, especially chemotherapy cycles to achieve hCG&#xD;
      normalization and failure to first-line chemotherapy.&#xD;
&#xD;
      Lung nodule &lt;1.0cm will directly treated as group C: follow up until hCG level met FIGO&#xD;
      diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 24, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>Parallel Assignment</intervention_model>
    <intervention_model_description>lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total.&#xD;
Lung nodule &lt;1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chemotherapy cycles</measure>
    <time_frame>20 month</time_frame>
    <description>chemotherapy cycles to achieve hCG normalization and failure to first line</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hCG declined to normal spontaneously of group B</measure>
    <time_frame>20</time_frame>
    <description>The proportion of patients with hCG level declined to normal spontaneously of group B</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>follow up of lung nodules</measure>
    <time_frame>32 month</time_frame>
    <description>the change of the lung nodules during follow up in group B and C</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hydatidiform Mole</condition>
  <condition>Gestational Trophoblastic Neoplasia</condition>
  <arm_group>
    <arm_group_label>A:chemotherapy immediately</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B:follow up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.&#xD;
B2: follow up until hCG level declined to normal spontaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow up</intervention_name>
    <description>the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.</description>
    <arm_group_label>B:follow up</arm_group_label>
    <other_name>not chemotherapy immediately</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>chemotherapy</intervention_name>
    <description>First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO</description>
    <arm_group_label>A:chemotherapy immediately</arm_group_label>
    <arm_group_label>B:follow up</arm_group_label>
    <other_name>mtx for low risk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. pathologic confirmed hydatidiform mole&#xD;
&#xD;
          2. the lung nodule was detected by lung CT at the suction evacuation of molar pregnancy&#xD;
             or during weekly hCG surveillance and lung metastasis cannot be excluded&#xD;
&#xD;
          3. the hCG level do not meet FIGO diagnostic criteria of GTN&#xD;
&#xD;
          4. good compliance&#xD;
&#xD;
          5. consent informed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of lung nodule&#xD;
&#xD;
          2. lung nodule was conformed as other diseases such as Tuberculosis, pneumonia&#xD;
&#xD;
          3. already accepted with chemotherapy or hysterectomy&#xD;
&#xD;
          4. pathologic confirmed GTN&#xD;
&#xD;
          5. immunosuppressive diseases status or take immunosuppressive drugs&#xD;
&#xD;
          6. Participating in other clinical trials&#xD;
&#xD;
          7. unable or unwilling to sign informed consent&#xD;
&#xD;
          8. cannot or unwilling to comply with research requirements&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xing Xie</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women's Hospital, Zhejiang University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao Li, dortor</last_name>
    <phone>008657189992206</phone>
    <email>5198008@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Weiguo Lv</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiguo Lv, Doctor</last_name>
      <phone>8657187061501</phone>
      <email>lixsure@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Women's Hospital School Of Medicine Zhejiang University</investigator_affiliation>
    <investigator_full_name>Xing Xie</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Nodule</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Chorionic Gonadotrophin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gestational Trophoblastic Disease</mesh_term>
    <mesh_term>Hydatidiform Mole</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/NCT03785574
org study id: CSEM 012
nct id: NCT03785574
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of present study is to provide clinical evidences for the appropriate management
      of molar pregnancy with lung nodule. The hydatidiform mole patients with lung nodule ≥1.0cm
      will be randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up
      until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal
      spontaneously (B2). Lung nodule <1.0cm will directly treated as group C
The hydatidiform mole patients with lung nodule ≥1.0cm will be randomized into 2 groups: A.
      treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic
      criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). The clinical
      characteristics of patients were compared, especially chemotherapy cycles to achieve hCG
      normalization and failure to first-line chemotherapy.

      Lung nodule <1.0cm will directly treated as group C: follow up until hCG level met FIGO
      diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: lung nodule ≥1.0cm were randomized into 2 groups: A. treated with chemotherapy immediately, B. follow up until hCG level met FIGO diagnostic criteria of GTN (B1) or hCG level declined to normal spontaneously (B2). A:B=1:2，the sample size of group A and group B was 30 in total.
Lung nodule <1.0cm will be directly treated as group C: follow up until hCG level met FIGO diagnostic criteria of GTN (C1) or hCG level declined to normal spontaneously (C2), it is an observation study and the sample volume depends on the enrolling time of group A and B.
primary purpose: Treatment
masking: None (Open Label)
measure: chemotherapy cycles
time frame: 20 month
description: chemotherapy cycles to achieve hCG normalization and failure to first line
measure: hCG declined to normal spontaneously of group B
time frame: 20
description: The proportion of patients with hCG level declined to normal spontaneously of group B
measure: follow up of lung nodules
time frame: 32 month
description: the change of the lung nodules during follow up in group B and C
arm group label: A:chemotherapy immediately
arm group type: Active Comparator
description: Treated with chemotherapy immediately. First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
arm group label: B:follow up
arm group type: Experimental
description: B1: follow up until hCG level met FIGO diagnostic criteria of GTN, then chemotherapy.
B2: follow up until hCG level declined to normal spontaneously.
intervention type: Other
intervention name: Follow up
description: the follow up group would be naturely didived into 2 subgroups depending the hCG regression degree.
arm group label: B:follow up
other name: not chemotherapy immediately
intervention type: Drug
intervention name: chemotherapy
description: First line treatments：low risk：Methotrexate or ACTD; high risk：EMA-CO
arm group label: A:chemotherapy immediately
arm group label: B:follow up
other name: mtx for low risk
criteria: 
gender: Female
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
last name: Xing Xie
role: Principal Investigator
affiliation: Women's Hospital, Zhejiang University School of Medicine
last name: Xiao Li, dortor
phone: 008657189992206
email: 5198008@zju.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Women's Hospital School Of Medicine Zhejiang University
investigator full name: Xing Xie
investigator title: Professor
mesh term: Gestational Trophoblastic Disease
mesh term: Hydatidiform Mole
sharing ipd: No