Hepatocellular CarcinomaINSIGHTNCT03233360
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
An observational study of Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 34 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 2,533 participants
- Where
- 34 sitesin 9 countries
- Study dates
- 17 Apr 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients participating in any HCC-related therapeutic/interventional clinical trial.
Trial locations and contacts
34 sites in 9 countries.
34 sites in 9 countries
South Korea8 sites
St Vincent Hospital, Catholic University Medical College
Gyeonggi-do, 16247
Ajou University Hospital
Gyeonggi-do, 16499
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Centre
Seoul, 05505
St. Mary's Hospital
Seoul, 131-701
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University College of Medicine
Seoul
China6 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Southwest Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, 400000
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Nanjing Bayi Hospital
Nanjing, Jiangsu, 210002
Guangxi Medical University Cancer Center
Nanning, Guangxi, 530021
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Taiwan5 sites
China Medical University Hospital
Taichung, 40402
National Cheng Kung University Hospital
Tainan
Chang Gung Memorial Hospital-KS
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Japan4 sites
National Cancer Centre, Japan
Chūōku, Tokyo, 104-0045
Kyorin University School of Medicine
Mitaka-shi, Tokyo, 181-8611
Kinki University School of Medicine
Ōsakasayama, Osaka, 589-8511
University of Tokyo
Tokyo
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, SA 5042
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Singapore3 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
National Cancer Centre
Singapore, 169610
Thailand3 sites
Chulabhorn Hospital
Bang Khen, Bangkok, 10210
Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
National Cancer Institute
Ratchathewi, Bangkok, 10400
About this study
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.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 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
Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Measured: 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
Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
Measured: From the start of treatment for a disease until disease progression, up to 2 years
Overall Survival Rate
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.
Measured: 5 years from date of diagnosis
Best Overall Response Rate (BORR)
The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
Measured: From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Measured: From treatment initiation to SD, CR or PR, up to 2 years
Disease Free Survival (DFS)
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
Measured: 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
The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
Measured: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Sites of recurrence
local/ regional / distant; specify site(s)
Measured: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Time to treatment recurrence
Measured: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start17 Apr 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, Singapore Clinical Research Institute, IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Pierce Chow, MD, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233360
- Sponsor's protocol ID
- AHCC08 INSIGHT
- Acronym
- INSIGHT
- Status last verified
- Nov 2022
- First submitted
- 18 Jul 2017
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
- ClinicalTrials.gov ID
- NCT03233360
- Acronym / sponsor ID
- INSIGHT / AHCC08 INSIGHT
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,533 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, Singapore Clinical Research Institute, IQVIA Pty Ltd
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- Patients participating in any HCC-related therapeutic/interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
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.
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
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
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
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
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)
Time to treatment recurrence
Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce Chow, MD, PhD principal investigator
National Cancer Centre, Singapore
34 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by National Cancer Centre, Singapore at 34 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in South Korea, China, Taiwan, Japan, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.