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Hepatocellular Carcinoma Registry in Asia

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ClinicalTrials.gov Identifier: NCT03233360
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborators:
Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
Singapore Clinical Research Institute
QuintilesIMS
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:
This registry is designed as a multi-centre longitudinal cohort study of patients diagnosed with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, 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.

Condition or disease
Hepatocellular Carcinoma

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Hepatocellular Carcinoma Registry in Asia
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  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    Patients lost for follow up or withdrawn from the study will be censored at the last disease assessment date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 ]


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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with HCC between 1st January 2013 and 30th June 2018 in nine countries (ie, Korea, Taiwan, Thailand, Japan, China, Hong Kong, Australia, New Zealand and Singapore).
Criteria

Inclusion Criteria:

  • Female or male aged 21 or above.
  • Patient with confirmed diagnosis of HCC between 1st January 2013 and 30th June 2018 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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233360


Contacts
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Contact: Pierce Chow, MD, PhD +6436 8000 pierce.chow.k.h@singhealth.com.sg

  Show 34 Study Locations
Sponsors and Collaborators
National Cancer Centre, Singapore
Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group
Singapore Clinical Research Institute
QuintilesIMS
Investigators
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Principal Investigator: Pierce Chow, MD, PhD National Cancer Centre, Singapore

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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03233360     History of Changes
Other Study ID Numbers: AHCC08
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases