<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/NCT03297255</url>
  </required_header>
  <id_info>
    <org_study_id>SYS-2013</org_study_id>
    <nct_id>NCT03297255</nct_id>
  </id_info>
  <brief_title>Primary Liver Cancer Cohort of South China</brief_title>
  <official_title>Factors Influencing the Occurrence and Long-term Survival of Patients With Primary Liver Cancer: A Cohort Study in South China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huilian Zhu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <brief_summary>
    <textblock>
      This longitudinal observational cohort study was designed to investigate factors that&#xD;
      influencing the occurrence and long-term survival of patients with primary liver cancer.&#xD;
      Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score,&#xD;
      Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes&#xD;
      (death, recurrence, and metastasis) will be followed up every two years after therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary liver cancer (PLC) is highly malignant with high mortality which is particularly&#xD;
      popular in China. Many factors are believed to associate with the occurrence and prognosis of&#xD;
      liver cancer. This longitudinal observational cohort study was designed to investigate&#xD;
      factors that influencing the occurrence and long-term survival of patients with primary liver&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Time of Death</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>The exact death time of each participants will be checked in the government medical records system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of recurrence</measure>
    <time_frame>From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years</time_frame>
    <description>Time of recurrence will be obtained by telephone interview or medical treatment records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of metastasis</measure>
    <time_frame>From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years</time_frame>
    <description>Time of metastasis will be obtained by telephone interview or medical treatment records</description>
  </secondary_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Primary Liver Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and liver tissue were retented during therapy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of this study were invited from Sun Yat-sen University Cancer Center as soon as&#xD;
        they were diagnosed as primary liver cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-80 years&#xD;
&#xD;
          -  consistent with primary liver cancer diagnostic criteria&#xD;
&#xD;
          -  first diagnosis (from diagnosis to admission interval of less than a month)&#xD;
&#xD;
          -  did not do any treatment of liver cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refused to participate in this study&#xD;
&#xD;
          -  suffering from more than two kinds of primary tumors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhu Huilian, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhu Huilian, Professor</last_name>
    <phone>+86 20 87331811</phone>
    <email>zhuhl@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fang Aiping</last_name>
    <phone>020-87335875</phone>
    <phone_ext>504</phone_ext>
    <email>fangaip@mail.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Minshan, Professor</last_name>
      <phone>+86 20 87343117</phone>
      <email>chenmsh@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Huilian Zhu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Primary Liver Cancer; Cohort Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT03297255
org study id: SYS-2013
nct id: NCT03297255
lead sponsor: 
This longitudinal observational cohort study was designed to investigate factors that
      influencing the occurrence and long-term survival of patients with primary liver cancer.
      Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score,
      Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes
      (death, recurrence, and metastasis) will be followed up every two years after therapy.
Primary liver cancer (PLC) is highly malignant with high mortality which is particularly
      popular in China. Many factors are believed to associate with the occurrence and prognosis of
      liver cancer. This longitudinal observational cohort study was designed to investigate
      factors that influencing the occurrence and long-term survival of patients with primary liver
      cancer.
observational model: Cohort
time perspective: Prospective
measure: Time of Death
time frame: Up to 10 years
description: The exact death time of each participants will be checked in the government medical records system
measure: Time of recurrence
time frame: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years
description: Time of recurrence will be obtained by telephone interview or medical treatment records
measure: Time of metastasis
time frame: From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years
description: Time of metastasis will be obtained by telephone interview or medical treatment records
Blood and liver tissue were retented during therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhu Huilian, Professor
role: Study Chair
affiliation: Sun Yat-sen University
last name: Zhu Huilian, Professor
phone: +86 20 87331811
email: zhuhl@mail.sysu.edu.cn
last name: Fang Aiping
phone: 020-87335875
phone ext: 504
email: fangaip@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Huilian Zhu
investigator title: Professor
mesh term: Liver Neoplasms