Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

Study Overview
=================
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.

Official Title
-----------------
Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 |  | From the time from a CR to treatment to the first recurrence of HCC, up to 2 years |