<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/NCT03283956</url>
  </required_header>
  <id_info>
    <org_study_id>201708028RINC</org_study_id>
    <nct_id>NCT03283956</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan</brief_title>
  <acronym>SERENADE-T</acronym>
  <official_title>Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan (SERENADE-T)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular&#xD;
      carcinoma in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular&#xD;
      carcinoma in Taiwan.&#xD;
&#xD;
      This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC&#xD;
      bead TACE in hepatocellular carcinoma (HCC) in Taiwan&#xD;
&#xD;
      Retrospective analysis of medical records of all patients who underwent DC Bead TACE at&#xD;
      National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung&#xD;
      Veterans General Hospital from 2010-2017/7.&#xD;
&#xD;
      All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY,&#xD;
      USA). Demographic and baseline lab data are presented by using descriptive statistics&#xD;
      Student's t-test. Survival analysis will includes all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 13, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of the DC bead TACE</measure>
    <time_frame>One year.</time_frame>
    <description>Safety of the DC bead TACE is evaluated based on the incidence of Grade 3 and Grade 4 toxicities up to 8 weeks following the procedure according to National Cancer Institute's Common Terminology Criteria for adverse events (CTCAE Version 4.03).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor response</measure>
    <time_frame>One year.</time_frame>
    <description>Tumor response is assessed on triphase CT or contrast-enhanced MR study according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Hepatocellular Carcinoma Non-resectable</condition>
  <condition>Chemoembolization, Therapeutic</condition>
  <arm_group>
    <arm_group_label>Patient records</arm_group_label>
    <description>Medical records of all patients who underwent DC bead TACE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Patient records</intervention_name>
    <description>Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7</description>
    <arm_group_label>Patient records</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Medical records of all patients who underwent DC bead TACE at National Taiwan University&#xD;
        Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital&#xD;
        from 2010-2017/7&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.&#xD;
&#xD;
          -  Patient received DC bead TACE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with current any other cancer except non-melanomatous skin cancer.&#xD;
&#xD;
          -  Infiltrative HCC&#xD;
&#xD;
          -  Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no&#xD;
             matter it is cTACE or DC bead TACE)&#xD;
&#xD;
          -  Patients received DC bead TACE and simultaneously received other therapy, such as&#xD;
             radiotherapy, sorafenib etc.&#xD;
&#xD;
          -  Presence of collateral vessel pathways potentially endangering normal territories&#xD;
             during embolization.&#xD;
&#xD;
          -  Presence of arteries supplying the lesion not large enough to accept DC Bead®&#xD;
             microspheres.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Hung Chen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chien-Hung Chen, MD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65923</phone_ext>
    <email>chenhcc@ntuh.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <contact>
      <last_name>Chien-Hung Chen, MD</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65923</phone_ext>
      <email>chenhcc@ntuh.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</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>
  </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/NCT03283956
org study id: 201708028RINC
nct id: NCT03283956
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular
      carcinoma in Taiwan.
To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular
      carcinoma in Taiwan.

      This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC
      bead TACE in hepatocellular carcinoma (HCC) in Taiwan

      Retrospective analysis of medical records of all patients who underwent DC Bead TACE at
      National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung
      Veterans General Hospital from 2010-2017/7.

      All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY,
      USA). Demographic and baseline lab data are presented by using descriptive statistics
      Student's t-test. Survival analysis will includes all patients.
observational model: Case-Control
time perspective: Retrospective
measure: Safety of the DC bead TACE
time frame: One year.
description: Safety of the DC bead TACE is evaluated based on the incidence of Grade 3 and Grade 4 toxicities up to 8 weeks following the procedure according to National Cancer Institute's Common Terminology Criteria for adverse events (CTCAE Version 4.03).
measure: Tumor response
time frame: One year.
description: Tumor response is assessed on triphase CT or contrast-enhanced MR study according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
arm group label: Patient records
description: Medical records of all patients who underwent DC bead TACE.
intervention type: Device
intervention name: Patient records
description: Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7
arm group label: Patient records
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chien-Hung Chen, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chien-Hung Chen, MD
phone: 886-2-23123456
phone ext: 65923
email: chenhcc@ntuh.gov.tw
facility: 
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No