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Completed

NCT Number: NCT03233360

Hepatocellular Carcinoma Registry in Asia: The INSIGHT Registry

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.

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Key information

Conditions

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

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: From diagnosis or treatment initiation to date of death due to any cause, or last known vital status date, up to 2 years

  2. Progression-free survival

    Time frame: 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

  3. Time to progression

    Time frame: 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.

  4. Overall Survival Rate

    Time frame: 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.

  5. Best Overall Response Rate (BORR)

    Time frame: 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

  6. Disease Control Rate (DCR)

    Time frame: 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

  7. Disease Free Survival (DFS)

    Time frame: 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

  8. Recurrence rate

    Time frame: 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

  9. Sites of recurrence

    Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years

    local/ regional / distant; specify site(s)

  10. Time to treatment recurrence

    Time frame: From the time from a CR to treatment to the first recurrence of HCC, up to 2 years

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
  • IQVIA Pty Ltd
  • Singapore Clinical Research Institute

Registry information

Acronym: INSIGHT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 28, 2017
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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