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

NCT05990959 | Unknown

• 1 other identifier: CMUH111-REC2-039
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma Recurrent; Surgery

Keywords

hepatocellular carcinoma; Recurrent; Surgery; Chemoprevention; National Health Insurance Research Database

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Overall survival

  5 year

• Disease free survival

  Disease free survival

  5 year

Study Arms (1)

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

Interventions

No intervention for research purpose OTHER

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.

HCC_surg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital, Department of Surgery

Taichung, 404, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen would be retrieved from already stored biobank in our own affiliation .The biospecimen may contain blood and liver tumors.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Chieh Yeh, Dr.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Chieh Yeh, Dr.

CONTACT

886975681449; Transplantyeh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 5, 2023
• First Posted: August 14, 2023
• Study Start: April 22, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)