Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

Hepatocellular Carcinoma Clinical Trial

— INSIGHT  

Official title:

Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233360
• Other study ID #: AHCC08 INSIGHT
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2022
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2533
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
China	Beijing Cancer Hospital	Beijing	Beijing
China	Southwest Hospital of Third Military Medical University	Chongqing	Chongqing
China	Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Nanjing Bayi Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Center	Nanning	Guangxi
China	Zhongshan Hospital	Shanghai	Shanghai
Hong Kong	Queen Mary Hospital	Hong Kong
Japan	National Cancer Centre, Japan	Chuoku	Tokyo
Japan	Kyorin University School of Medicine	Mitaka-shi	Tokyo
Japan	Kinki University School of Medicine	Osakasayama	Osaka
Japan	University of Tokyo	Tokyo
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	St Vincent Hospital, Catholic University Medical College	Gyeonggi-do
Korea, Republic of	Asan Medical Centre	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul
Korea, Republic of	St. Mary's Hospital	Seoul
New Zealand	Auckland City Hospital	Grafton	Auckland
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chang Gung Memorial Hospital-KS	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Chulabhorn Hospital	Bang Khen	Bangkok
Thailand	Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok
Thailand	National Cancer Institute	Ratchathewi	Bangkok

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, Iqvia Pty Ltd, Singapore Clinical Research Institute

Countries where clinical trial is conducted

Australia,  China,  Hong Kong,  Japan,  Korea, Republic of,  New Zealand,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Time to treatment recurrence		From the time from a CR to treatment to the first recurrence of HCC, up to 2 years