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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Centre, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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