<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/NCT03291236</url>
  </required_header>
  <id_info>
    <org_study_id>SOCM-1</org_study_id>
    <nct_id>NCT03291236</nct_id>
  </id_info>
  <brief_title>Survival Outcomes of Uterine Cervical Malignancies in Chinese Population</brief_title>
  <official_title>Survival Outcomes of Uterine Cervical Malignancies in Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College 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 aims to determine survival outcomes (overall survival and progression-free&#xD;
      survival) of primary malignancies of uterine cervix in China and relevant risk factors in a&#xD;
      prospective cohort study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>Duration from diagnosis to recurrence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>Duration from last treatment after remission to recurrence</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Uterine Cervical Neoplasms</condition>
  <condition>Survival</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Follow-up for death and recurrence of patients</intervention_name>
    <description>All patients are follow-up to determine specific date of diagnosis, recurrence and death.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with primary malignancies of uterine cervix in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary malignancies of uterine cervix.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary malignancies of uternie cervix.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, MD</last_name>
    <phone>13911988831</phone>
    <phone_ext>+86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>+86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical 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/NCT03291236
org study id: SOCM-1
nct id: NCT03291236
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to determine survival outcomes (overall survival and progression-free
      survival) of primary malignancies of uterine cervix in China and relevant risk factors in a
      prospective cohort study.
observational model: Cohort
time perspective: Prospective
measure: Overall survival
time frame: 5 years
description: Duration from diagnosis to recurrence
measure: Progression-free survival
time frame: 5 years
description: Duration from last treatment after remission to recurrence
intervention type: Other
intervention name: Follow-up for death and recurrence of patients
description: All patients are follow-up to determine specific date of diagnosis, recurrence and death.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lei Li, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li, MD
phone: 13911988831
phone ext: +86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No