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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05613621

Acronym

T4222

Enrollment

579

Registered

2022-11-14

Start date

2025-08-14

Completion date

2026-12-31

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, next-generation sequencing, precision medicine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results