Dissection of the Molecular and Immunological Interaction in Patients With HCC of Viral and Non-viral Etiologies

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05613621
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief Summary

This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.

Detailed Description

This study will start with a "training cohort" of the NTUH and NTU Cancer Center patients, consisting of 4 sub-groups: HBV (+) steatosis (+), HBV (-) steatosis (+), HBV (+) steatosis (-) and HBV (-) steatosis (-). HBV (+) is defined as either: (a) HBsAg (+) or (b) HBsAg (-) anti-HBc (+) and HBV DNA detectable in blood or tumor tissue. Steatosis is defined by histology. We will enroll 400 patients who had sufficient tissue for testing in the training cohort. The following studies will be performed: (1) NGS of targeted genes panel using the National Health Research Institutes precision medicine platform; (2) transcriptomic analysis of immune microenvironment using RNA-seq and multiplex immunofluorescence staining; (3) lipotoxic genotyping for SNPs; (4) clinical outcomes of MAFLD vs. non-MAFLD. The genetic and immunological features will be further tested by a "validation cohort", from collaborative hospitals. This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-14
• Study Start: 2022-11-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Adult female or male patients aged ≥20 years.
2. HCC has been histologically confirmed with resection specimen.
3. The surgery should be performed with curative intent after 2015 in the study hospital.
4. Availability of serum HBsAg and Anti-HBc data in the electronic medical record.
5. Availability of imaging data performed within 3 months before the surgery in the electronic medical record. (at least one of the following: computed tomography, magnetic resonance imaging, abdominal sonography).
6. Informed consent is obtained. Willingness to provide the residual operative slides and medical records.

Exclusion Criteria

1. Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC
2. Exclusion of HCV patients (Anti-HCV positive)
3. Inability to cooperate by providing a complete medical history.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
transcriptomic analysis of immune microenvironment	2 Years	using RNA-seq and multiplex immunofluorescence staining
lipotoxic genotyping for SNPs	2 years	lipotoxic genotyping for SNPs
clinical outcomes of MAFLD vs. non-MAFLD.	2 years	clinical outcomes of MAFLD vs. non-MAFLD.

Trial Locations

Locations (4)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Cancer Center; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan