Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

NCT03233360 | Completed

• 1 other identifier: AHCC08 INSIGHT
• Study Type: observational
• Target: 2,533
• Locations: 9 countries
• Sites: 34

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (10)

• 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  Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date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

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• \- Patients participating in any HCC-related therapeutic/interventional clinical trial.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group: collaborator
• Singapore Clinical Research Institute: collaborator
• Iqvia Pty Ltd: collaborator

Study Sites (34)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, SA 5042, Australia

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Southwest Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Guangxi Medical University Cancer Center

Nanning, Guangxi, 530021, China

Location

Nanjing Bayi Hospital

Nanjing, Jiangsu, 210002, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Kinki University School of Medicine

Ōsakasayama, Osaka, 589-8511, Japan

Location

National Cancer Centre, Japan

Chūōku, Tokyo, 104-0045, Japan

Location

Kyorin University School of Medicine

Mitaka-shi, Tokyo, 181-8611, Japan

Location

University of Tokyo

Tokyo, Japan

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

St Vincent Hospital, Catholic University Medical College

Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 16499, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Centre

Seoul, 05505, South Korea

Location

St. Mary's Hospital

Seoul, 131-701, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

China Medical University Hospital

Taichung, 40402, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Chang Gung Memorial Hospital-KS

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chulabhorn Hospital

Bang Khen, Bangkok, 10210, Thailand

Location

Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

National Cancer Institute

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Pierce Chow, MD, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 28, 2017
• Study Start: April 17, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); JP (4); CN (6); SG (3); AU (3); TW (5); TH (3); KR (8); HK (1)