Clinical trial NCT03233360: Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
Official title: Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
name: Singapore Clinical Research Institute
name: Iqvia Pty Ltd
First posted: 2017-07-28
Enrollment: 2533
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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.


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.

Primary outcomes:
measure: Overall Survival
timeFrame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years
measure: Progression-free survival
timeFrame: 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
measure: Time to progression
timeFrame: From the start of treatment for a disease until disease progression, up to 2 years
measure: Overall Survival Rate
timeFrame: 5 years from date of diagnosis
measure: Best Overall Response Rate (BORR)
timeFrame: From treatment initiation to CR or PR, up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: From treatment initiation to SD, CR or PR, up to 2 years
measure: Disease Free Survival (DFS)
timeFrame: 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
measure: Recurrence rate
timeFrame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
measure: Sites of recurrence
timeFrame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
measure: Time to treatment recurrence
timeFrame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital of Third Military Medical University
state: Chongqing
city: Nanning
country: China
facility: Guangxi Medical University Cancer Center
state: Guangxi
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Ōsakasayama
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Chūōku
country: Japan
facility: National Cancer Centre, Japan
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Tokyo
country: Japan
facility: University of Tokyo
city: Gyeonggi-do
country: Korea, Republic of
facility: St Vincent Hospital, Catholic University Medical College
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Centre
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital-KS
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bang Khen
country: Thailand
facility: Chulabhorn Hospital
state: Bangkok
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital, Mahidol University
state: Bangkok
city: Ratchathewi
country: Thailand
facility: National Cancer Institute
state: Bangkok
Study officials:
affiliation: National Cancer Centre, Singapore
name: Pierce Chow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: