Risk Factors, Prognosis, and Potential Chemoprevention Drugs in Patients With Recurrent Hepatocellular Carcinoma After Curative Surgeries: a Nationwide Retrospective Cohort Study and a Multi-center Prospective Cohort Analysis

August 5, 2023 updated by: Chun Chieh Yeh, China Medical University Hospital

Backgrounds: Surgeries are the mainstream of curative therapies for hepatocellular carcinoma (HCC). However, high risk of recurrent HCC after liver surgeries is still the unsolved clinical issue (early recurrence 21% per year; late recurrence 18% per year). Early recurrence mainly result from disseminated HCC; by contrast, late recurrence usually originate from carcinogenic microenvironment. Currently, no large-scale nationwide studies that integrate laboratory date and clinical information was performed to investigate risk factors and prognosis of post-operative recurrent HCC. Besides, owing to economic issue, few companies would initiate pharmacologic studies to investigate chemoprevention agents for HCC. Furthermore, few biomarkers were discovered from Taiwanese HCC cohort to predict post-operative tumor recurrence because of no standardized cooperative platforms to share biological tissue and clinical information. Therefore, we wish to utilize a nationwide retrospective cohort from integrated national health insurance database (NHIRD) and a prospective multi-center clinical cohort study to address aforementioned issues.

Aims:

  1. Investigate risk factors and prognosis of post-operative recurrent HCC in Taiwanese cohort
  2. Discover chemoprevention targets from generic drugs to reduce risk of post-operative recurrent HCC
  3. Determine biomarkers from Taiwanese cohort in prediction of post-operative recurrent HCC

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study subject and methods:

Nationwide retrospective cohort study

  1. Establish prediction models for postoperative recurrent HCC by analyzing surgical HCC patients' clinical information and perioperative laboratory date based on the database of a nationwide retrospective cohort organized by the Ministry of Health and Welfare and Health insurance office
  2. Discover chemoprevention agents in association with reduced risk of post-operative recurrent HCC using the aforementioned database

Multicenter prospective cohort study:

  1. To discover biomarkers in prediction of post-operative recurrent HCC , we will establish a shared platform to prospectively and systemically collect Taiwanese HCC surgical patients' bio-materials and clinical information from China Medical University Hospital, Asian University Hospital, Mackay Hospital, Taichung Veterans General Hospital, E-Da Hospital,…etc.
  2. Using the multicenter prospective cohort, we could validate the results from the nationwide retrospective cohort study, and even improve the prediction models by adding biological parameters that are not available in the nationwide retrospective cohort

Hospital biobank based retrospective case-control study Investigate clinical and biological parameters in prediction of tumor recurrence in HCC surgical patients by hospital based biobank and relevant clinical information

Laboratory in-vivo and in-vitro study Investigate causal relationship between prognosis of HCC and selected biomarkers from above studies as well as four universal tumor theragnostic markers (ADAM9, MTHFD2, RRM2, and SLC2A1) and explore treatment effects of corresponding inhibitors

Expected results: For scientists, they may benefit from the shared database of Taiwanese HCC surgical patients for the HCC related researches; for physicians, they could predict risk of post-operative recurrent HCC in Taiwanese HCC patients and use generic drugs as potentially chemopreventive drugs for HCC; for patients, they could benefit from the personalized medical advice to increase the survival; for the authorities, they could design a policy to reduce the risk of post-operative recurrent HCC, and even prolong HCC patients' survival in a cost-effective way by using generic drugs as chemopreventive regimens for HCC.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital, Department of Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries that would be performed under best clinical judgment, NOT for research purpose.

Description

Inclusion Criteria:

  • All HCC surgical patients aged more than 20 year-old who sign informed consent for donating remnant tissue or blood after liver surgeries

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC_surg
HCC surgical patients who would receive surgical interventions based on clinical judgment and would donate biospecimen for research after signing informed consent permission.
Other: No intervention for research purpose
No any intervention will be applied under research purpose. All procedure or drugs would be given to the patient under best clinical judgment, not for research purpose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 year
Overall survival
5 year
Disease free survival
Time Frame: 5 year
Disease free survival
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

Investigators

  • Principal Investigator: Chun-Chieh Yeh, Dr., China Medical University Hospital,Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

August 5, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 5, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH111-REC2-039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All patient's privacy would be protected under our IRB regulation. Thus, I cannot release IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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