<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/NCT03233360</url>
  </required_header>
  <id_info>
    <org_study_id>AHCC08 INSIGHT</org_study_id>
    <nct_id>NCT03233360</nct_id>
  </id_info>
  <brief_title>Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry</brief_title>
  <acronym>INSIGHT</acronym>
  <official_title>Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore Clinical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Iqvia Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Centre, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific')&#xD;
      registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with&#xD;
      HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea,&#xD;
      Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore).&#xD;
      Approximately 30% of the sample size will be identified retrospectively and 70% will be&#xD;
      identified prospectively from the start date of the registry (October 2016), with an even&#xD;
      distribution of consecutively diagnosed patients within the different years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From treatment initiation for advanced or metastatic HCC to the first date of disease progression or death due to any cause, whichever occurred first, up to 2 years</time_frame>
    <description>Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to progression</measure>
    <time_frame>From the start of treatment for a disease until disease progression, up to 2 years</time_frame>
    <description>Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival Rate</measure>
    <time_frame>5 years from date of diagnosis</time_frame>
    <description>The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Best Overall Response Rate (BORR)</measure>
    <time_frame>From treatment initiation to CR or PR, up to 2 years</time_frame>
    <description>The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>From treatment initiation to SD, CR or PR, up to 2 years</time_frame>
    <description>The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Free Survival (DFS)</measure>
    <time_frame>From the time from completing adjuvant/neoadjuvant treatment to the date of HCC recurrence, or the date of death due to any cause, whichever occurred first, up to 2 years</time_frame>
    <description>Patients lost for follow up will be censored at the last disease assessment date; DFS rate at 2 years - defined as the proportion of HCC patients who are alive and cancer free 2 years after completion of adjuvant/neoadjuvant treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence rate</measure>
    <time_frame>From the time from a CR to treatment to the first recurrence of HCC, up to 2 years</time_frame>
    <description>The proportion of patients who experience a recurrence of HCC after having had a CR to treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sites of recurrence</measure>
    <time_frame>From the time from a CR to treatment to the first recurrence of HCC, up to 2 years</time_frame>
    <description>local/ regional / distant; specify site(s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to treatment recurrence</measure>
    <time_frame>From the time from a CR to treatment to the first recurrence of HCC, up to 2 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">2533</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with HCC between 1st January 2013 and 31st December 2019 in nine&#xD;
        countries (i.e., South Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New&#xD;
        Zealand and Singapore).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male aged 21 or above.&#xD;
&#xD;
          -  Patient with confirmed diagnosis of HCC between 1st January 2013 and 31st December&#xD;
             2019 based on one or more of the following criteria:&#xD;
&#xD;
               -  American Association for the Study of Liver Diseases (AASLD) criteria&#xD;
&#xD;
               -  Asian Pacific Association for the Study of the Liver (APASL) criteria&#xD;
&#xD;
               -  Histology/cytology&#xD;
&#xD;
               -  Space occupying lesion in the liver and an serum alpha-feto protein of &gt; 400&#xD;
                  ng/mL in a patient with chronic viral hepatitis or cirrhosis from any cause&#xD;
&#xD;
          -  Informed consent form (ICF) to be presented and signed by patients who are still alive&#xD;
             at the point of study enrolment, per local regulations. For the collection of data for&#xD;
             deceased subjects, appropriate waiver of consent as per local regulations and&#xD;
             guidelines will have to be in place.&#xD;
&#xD;
          -  Patient who is being followed-up at the participating site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients participating in any HCC-related therapeutic/interventional clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierce Chow, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Centre, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>SA 5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Hospital of Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangxi Medical University Cancer Center</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Bayi Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinki University School of Medicine</name>
      <address>
        <city>Ōsakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre, Japan</name>
      <address>
        <city>Chūōku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University School of Medicine</name>
      <address>
        <city>Mitaka-shi</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tokyo</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent Hospital, Catholic University Medical College</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Centre</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>131-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital-KS</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chulabhorn Hospital</name>
      <address>
        <city>Bang Khen</city>
        <state>Bangkok</state>
        <zip>10210</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok Noi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Ratchathewi</city>
        <state>Bangkok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>Hong Kong</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2022</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/NCT03233360
org study id: AHCC08 INSIGHT
nct id: NCT03233360
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The INSIGHT ('Insight into Real-world Practice of Management of HCC in Asia-Pacific')
      registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with
      HCC between 1st January 2013 and 31st December 2019 in nine countries (i.e., South Korea,
      Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore).
      Approximately 30% of the sample size will be identified retrospectively and 70% will be
      identified prospectively from the start date of the registry (October 2016), with an even
      distribution of consecutively diagnosed patients within the different years.
observational model: Cohort
time perspective: Other
measure: Overall Survival
time frame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
measure: Progression-free survival
time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression or death due to any cause, whichever occurred first, up to 2 years
description: Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
measure: Time to progression
time frame: From the start of treatment for a disease until disease progression, up to 2 years
description: Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
measure: Overall Survival Rate
time frame: 5 years from date of diagnosis
description: The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after their diagnosis or the start of treatment. Also called survival rate.
measure: Best Overall Response Rate (BORR)
time frame: From treatment initiation to CR or PR, up to 2 years
description: The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
measure: Disease Control Rate (DCR)
time frame: From treatment initiation to SD, CR or PR, up to 2 years
description: The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
measure: Disease Free Survival (DFS)
time frame: From the time from completing adjuvant/neoadjuvant treatment to the date of HCC recurrence, or the date of death due to any cause, whichever occurred first, up to 2 years
description: Patients lost for follow up will be censored at the last disease assessment date; DFS rate at 2 years - defined as the proportion of HCC patients who are alive and cancer free 2 years after completion of adjuvant/neoadjuvant treatment
measure: Recurrence rate
time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
description: The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
measure: Sites of recurrence
time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
description: local/ regional / distant; specify site(s)
measure: Time to treatment recurrence
time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pierce Chow, MD, PhD
role: Principal Investigator
affiliation: National Cancer Centre, Singapore
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country: Australia
country: China
country: Hong Kong
country: Japan
country: Korea, Republic of
country: New Zealand
country: Singapore
country: Taiwan
country: Thailand
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No