The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03233360




Registration number
NCT03233360
Ethics application status
Date submitted
18/07/2017
Date registered
28/07/2017
Date last updated
28/07/2017

Titles & IDs
Public title
Hepatocellular Carcinoma Registry in Asia
Scientific title
Hepatocellular Carcinoma Registry in Asia
Secondary ID [1] 0 0
AHCC08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
Primary outcome [2] 0 0
Progression-free survival - Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
Time to progression - Measuring the time to progression is one way to see how well a new treatment works. Also called TTP.
Timepoint [3] 0 0
From the start of treatment for a disease until disease progression, up to 2 years
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
5 years from date of diagnosis
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
From treatment initiation to CR or PR, up to 2 years
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
From treatment initiation to SD, CR or PR, up to 2 years
Primary outcome [7] 0 0
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
Timepoint [7] 0 0
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
Primary outcome [8] 0 0
Recurrence rate - The proportion of patients who experience a recurrence of HCC after having had a CR to treatment
Timepoint [8] 0 0
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Primary outcome [9] 0 0
Sites of recurrence - local/ regional / distant; specify site(s)
Timepoint [9] 0 0
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Primary outcome [10] 0 0
Time to treatment recurrence
Timepoint [10] 0 0
From the time from a CR to treatment to the first recurrence of HCC, up to 2 years

Eligibility
Key inclusion criteria
- Female or male aged 21 or above.

- Patient with confirmed diagnosis of HCC between 1st January 2013 and 30th June 2018
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 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.
Minimum age
21 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients participating in any HCC-related therapeutic/interventional clinical trial.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
SA 5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chongqing
Country [3] 0 0
China
State/province [3] 0 0
Guangxi
Country [4] 0 0
China
State/province [4] 0 0
Jiangsu
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
China
State/province [6] 0 0
Zhejiang
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Japan
State/province [8] 0 0
Osaka
Country [9] 0 0
Japan
State/province [9] 0 0
Tokyo
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Gyeonggi-do
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
Singapore
State/province [13] 0 0
Singapore
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taichung
Country [15] 0 0
Taiwan
State/province [15] 0 0
Tainan
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei
Country [17] 0 0
Thailand
State/province [17] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
National Cancer Centre, Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Singapore Clinical Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
QuintilesIMS
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed
with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, 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.
Trial website
https://clinicaltrials.gov/show/NCT03233360
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pierce Chow, MD, PhD
Address 0 0
National Cancer Centre, Singapore
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pierce Chow, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+6436 8000
Fax 0 0
Email 0 0
pierce.chow.k.h@singhealth.com.sg
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03233360