Hepatocellular Carcinoma
Conditions
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.
Interventions
None listed
Sponsors
National Cancer Centre, Singapore
Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
Singapore Clinical Research Institute
Iqvia Pty Ltd
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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disease progression or death due to any cause, whichever occurred first, up to 2 years | Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date |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. |
| 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 |
| 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 |
| 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 |
| 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 | — |
Countries
Australia, China, Hong Kong, Japan, New Zealand, Singapore, South Korea, Taiwan, Thailand
Outcome results
None listed