Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry (INSIGHT)

November 30, 2022 updated by: National Cancer Centre, Singapore
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, SA 5042
        • Flinders Medical Centre
  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Southwest Hospital of Third Military Medical University
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Cancer Center
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Nanjing Bayi Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital ZheJiang University School of Medicine
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Japan
      • Tokyo, Japan
        • University of Tokyo
    • Osaka
      • Ōsakasayama, Osaka, Japan, 589-8511
        • Kinki University School of Medicine
    • Tokyo
      • Chūōku, Tokyo, Japan, 104-0045
        • National Cancer Centre, Japan
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University School of Medicine
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • St Vincent Hospital, Catholic University Medical College
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University College of Medicine
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Centre
      • Seoul, Korea, Republic of, 131-701
        • St. Mary's Hospital
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Taiwan
      • Taichung, Taiwan, 40402
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Chang Gung Memorial Hospital-KS
  • Thailand
    • Bangkok
      • Bang Khen, Bangkok, Thailand, 10210
        • Chulabhorn Hospital
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Siriraj Hospital, Mahidol University
      • Ratchathewi, Bangkok, Thailand, 10400
        • National Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  • Female or male aged 21 or above.

  • Patient with confirmed diagnosis of HCC between 1st January 2013 and 31st December 2019 based on one or more of the following criteria:

    • American Association for the Study of Liver Diseases (AASLD) criteria
    • Asian Pacific Association for the Study of the Liver (APASL) criteria
    • Histology/cytology
    • Space occupying lesion in the liver and an serum alpha-feto protein of > 400 ng/mL in a patient with chronic viral hepatitis or cirrhosis from any cause
  • Informed consent form (ICF) to be presented and signed by patients who are still alive at the point of study enrolment, per local regulations. For the collection of data for deceased subjects, appropriate waiver of consent as per local regulations and guidelines will have to be in place.
  • Patient who is being followed-up at the participating site.

Exclusion Criteria:

- Patients participating in any HCC-related therapeutic/interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
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
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
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 to progression
Time Frame: From the start of treatment for a disease until disease progression, up to 2 years
Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
From the start of treatment for a disease until disease progression, up to 2 years
Overall Survival Rate
Time Frame: 5 years from date of diagnosis
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.
5 years from date of diagnosis
Best Overall Response Rate (BORR)
Time Frame: From treatment initiation to CR or PR, up to 2 years
The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
Time Frame: From treatment initiation to SD, CR or PR, up to 2 years
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
From treatment initiation to SD, CR or PR, up to 2 years
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
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
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
Recurrence rate
Time Frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Sites of recurrence
Time Frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
local/ regional / distant; specify site(s)
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Time to treatment recurrence
Time Frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Iqvia Pty Ltd
Singapore Clinical Research Institute
Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 17, 2017

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHCC08 INSIGHT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe