Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT03233360
- Lead Sponsor
- National Cancer Centre, Singapore
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2533
-
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.
- Patients participating in any HCC-related therapeutic/interventional clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence rate 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
Disease Control Rate (DCR) 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) 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
Best Overall Response Rate (BORR) 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
Overall Survival 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 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 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 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.
Sites of recurrence 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 From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Southwest Hospital of Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Guangxi Medical University Cancer Center
🇨🇳Nanning, Guangxi, China
Nanjing Bayi Hospital
🇨🇳Nanjing, Jiangsu, China
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Scroll for more (24 remaining)Royal Prince Alfred Hospital🇦🇺Camperdown, New South Wales, Australia