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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03233360
Registration number
NCT03233360
Ethics application status
Date submitted
18/07/2017
Date registered
28/07/2017
Date last updated
5/12/2022
Titles & IDs
Public title
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
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Scientific title
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
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Secondary ID [1]
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AHCC08 INSIGHT
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Universal Trial Number (UTN)
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Trial acronym
INSIGHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Liver
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Timepoint [1]
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From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
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Primary outcome [2]
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Progression-free survival
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Assessment method [2]
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Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
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Timepoint [2]
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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
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Primary outcome [3]
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Time to progression
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Assessment method [3]
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Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
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Timepoint [3]
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From the start of treatment for a disease until disease progression, up to 2 years
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Primary outcome [4]
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Overall Survival Rate
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Assessment method [4]
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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.
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Timepoint [4]
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5 years from date of diagnosis
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Primary outcome [5]
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Best Overall Response Rate (BORR)
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Assessment method [5]
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The proportion of patients who had either a complete response (CR) or partial response (PR) after initiation of treatment for HCC
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Timepoint [5]
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From treatment initiation to CR or PR, up to 2 years
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Primary outcome [6]
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Disease Control Rate (DCR)
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Assessment method [6]
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The proportion of patients who had either stable disease (SD) for = 6 months, a CR or PR after initiation of treatment for HCC
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Timepoint [6]
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From treatment initiation to SD, CR or PR, up to 2 years
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Primary outcome [7]
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Disease Free Survival (DFS)
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Assessment method [7]
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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
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Timepoint [7]
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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
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Primary outcome [8]
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Recurrence rate
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Assessment method [8]
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The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
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Timepoint [8]
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From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
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Primary outcome [9]
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Sites of recurrence
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Assessment method [9]
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local/ regional / distant; specify site(s)
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Timepoint [9]
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From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
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Primary outcome [10]
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Time to treatment recurrence
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Assessment method [10]
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Timepoint [10]
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From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
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Eligibility
Key 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.
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Minimum age
21
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients participating in any HCC-related therapeutic/interventional clinical trial.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2020
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Sample size
Target
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Accrual to date
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Final
2533
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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SA 5042 - Bedford Park
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Chongqing
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Country [3]
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China
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State/province [3]
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Guangxi
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Country [4]
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China
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State/province [4]
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Jiangsu
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Country [5]
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China
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State/province [5]
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Shanghai
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Country [6]
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China
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State/province [6]
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Zhejiang
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Country [7]
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Hong Kong
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State/province [7]
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Hong Kong
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Country [8]
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Japan
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State/province [8]
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Osaka
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Country [9]
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Japan
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State/province [9]
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Tokyo
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Country [10]
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Korea, Republic of
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State/province [10]
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Gyeonggi-do
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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New Zealand
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State/province [12]
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Auckland
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Country [13]
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Singapore
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State/province [13]
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Singapore
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Country [14]
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Taiwan
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State/province [14]
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Taichung
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Country [15]
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Taiwan
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State/province [15]
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Tainan
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Country [16]
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Taiwan
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State/province [16]
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Taipei
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Country [17]
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Thailand
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State/province [17]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Other
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Name
National Cancer Centre, Singapore
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Singapore Clinical Research Institute
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Address [2]
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Country [2]
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Other collaborator category [3]
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Commercial sector/Industry
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Name [3]
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Iqvia Pty Ltd
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief 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, 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03233360
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pierce Chow, MD, PhD
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Address
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National Cancer Centre, Singapore
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03233360
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