<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/NCT03285867</url>
  </required_header>
  <id_info>
    <org_study_id>liuhy</org_study_id>
    <nct_id>NCT03285867</nct_id>
  </id_info>
  <brief_title>Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma</brief_title>
  <official_title>Value of Liver Stiffness Measurement (LSM) in Predicting the Progress of Liver Fibrosis After Transcatheter Arterial Chemoembolization (TACE) for Hepatocellular Carcinoma, an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</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>
      Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by&#xD;
      FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter&#xD;
      arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).&#xD;
&#xD;
      Background: Progress of liver fibrosis and liver failure and related poor prognosis after&#xD;
      TACE which are not completely predictable by current method including Child-Pugh&#xD;
      Classification. LSM is used to calculate the degree of liver fibrosis and is affected by&#xD;
      several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate&#xD;
      transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to&#xD;
      predict progress of liver fibrosis and adverse effects after TACE in HCC.&#xD;
&#xD;
      Methods: At least 200 patients will be recruited in this prospective observational study with&#xD;
      preoperative LSM, demographic, laboratory, radiological and other treatment-related factors.&#xD;
      Participants will be followed up till death or to the end of study no matter the liver&#xD;
      failure occurs or not. Data will be analyzed to build a mathematical predicting model.&#xD;
&#xD;
      Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model&#xD;
      with LSM is able to predict the risk of liver failure and prognosis in HCC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 25, 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)</measure>
    <time_frame>within 1 week pre-TACE and 1 week post-TACE</time_frame>
    <description>The investigators will investigate the value of LSM( kpa) by machine of FibroScan ( produced by France Echo).&#xD;
The investigators will record LSMs before and after each procedure of TACE. The investigators will calculate the change of LSMs of each participants.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Liver Failure</condition>
  <arm_group>
    <arm_group_label>HCC received TACE</arm_group_label>
    <description>observational study set only one group with HCC received TACE</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TACE</intervention_name>
    <description>transcatheter arterial chemoembolization</description>
    <arm_group_label>HCC received TACE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients admitted to our department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age：18-80&#xD;
&#xD;
          -  HCC diagnosed by pathologist or physician according to Guidelines&#xD;
&#xD;
          -  Chronic Hepatitis B (CHB) background&#xD;
&#xD;
          -  receive at least 1 TACE&#xD;
&#xD;
          -  volunteer to join the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  massive lesion with insufficient liver left for LSM examination&#xD;
&#xD;
          -  associated with other liver diseases: Chronic Hepatitis C(CHC),Autoimmune&#xD;
             Hepatitis(AIH),Wilson's disease.&#xD;
&#xD;
          -  severe obesity(BMI&gt;28)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  other inappropriate situation defined by investigators.&#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_contact>
    <last_name>wang kunyuan</last_name>
    <phone>0086-020-62787430</phone>
    <email>390671613@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>liu hongyan</last_name>
    <phone>0086-020-62787631</phone>
    <email>liuhongyan205628@163.com</email>
  </overall_contact_backup>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>April 27, 2018</last_update_submitted>
  <last_update_submitted_qc>April 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Liver Cirrhosis</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/NCT03285867
org study id: liuhy
nct id: NCT03285867
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by
      FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter
      arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC).

      Background: Progress of liver fibrosis and liver failure and related poor prognosis after
      TACE which are not completely predictable by current method including Child-Pugh
      Classification. LSM is used to calculate the degree of liver fibrosis and is affected by
      several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate
      transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to
      predict progress of liver fibrosis and adverse effects after TACE in HCC.

      Methods: At least 200 patients will be recruited in this prospective observational study with
      preoperative LSM, demographic, laboratory, radiological and other treatment-related factors.
      Participants will be followed up till death or to the end of study no matter the liver
      failure occurs or not. Data will be analyzed to build a mathematical predicting model.

      Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model
      with LSM is able to predict the risk of liver failure and prognosis in HCC.
observational model: Cohort
time perspective: Prospective
measure: The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)
time frame: within 1 week pre-TACE and 1 week post-TACE
description: The investigators will investigate the value of LSM( kpa) by machine of FibroScan ( produced by France Echo).
The investigators will record LSMs before and after each procedure of TACE. The investigators will calculate the change of LSMs of each participants.
arm group label: HCC received TACE
description: observational study set only one group with HCC received TACE
intervention type: Procedure
intervention name: TACE
description: transcatheter arterial chemoembolization
arm group label: HCC received TACE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: wang kunyuan
phone: 0086-020-62787430
email: 390671613@qq.com
last name: liu hongyan
phone: 0086-020-62787631
email: liuhongyan205628@163.com
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Failure
mesh term: Liver Cirrhosis
sharing ipd: No