Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

Completed

• 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

Study Timeline

• Study Start: 2017-04-17
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2533

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.

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

Trial Locations

Locations (34)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

National Cancer Centre, Japan; 🇯🇵 Chūōku, Tokyo, Japan

St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Kyorin University School of Medicine; 🇯🇵 Mitaka-shi, Tokyo, Japan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Guangxi Medical University Cancer Center; 🇨🇳 Nanning, Guangxi, China

Chulabhorn Hospital; 🇹🇭 Bang Khen, Bangkok, Thailand

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand

National Cancer Institute; 🇹🇭 Ratchathewi, Bangkok, Thailand

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

Nanjing Bayi Hospital; 🇨🇳 Nanjing, Jiangsu, China

Southwest Hospital of Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Kinki University School of Medicine; 🇯🇵 Ōsakasayama, Osaka, Japan

St Vincent Hospital, Catholic University Medical College; 🇰🇷 Gyeonggi-do, Korea, Republic of

University of Tokyo; 🇯🇵 Tokyo, Japan

Ajou University Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Asan Medical Centre; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

National University Hospital; 🇸🇬 Singapore, Singapore

Auckland City Hospital; 🇳🇿 Grafton, Auckland, New Zealand

National Cancer Centre; 🇸🇬 Singapore, Singapore

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Chang Gung Memorial Hospital-KS; 🇨🇳 Taipei, Taiwan

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

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong