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NCT Number: NCT05613621

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng-Kung University Hospital, Tainan, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult female or male patients aged ≥20 years.
  • HCC has been histologically confirmed with resection specimen.
  • The surgery should be performed with curative intent after 2015 in the study hospital.
  • Availability of serum HBsAg and Anti-HBc data in the electronic medical record.
  • 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).
  • Informed consent is obtained. Willingness to provide the residual operative slides and medical records.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. transcriptomic analysis of immune microenvironment

    Time frame: 2 Years

    using RNA-seq and multiplex immunofluorescence staining

  2. lipotoxic genotyping for SNPs

    Time frame: 2 years

    lipotoxic genotyping for SNPs

  3. clinical outcomes of MAFLD vs. non-MAFLD.

    Time frame: 2 years

    clinical outcomes of MAFLD vs. non-MAFLD.

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • Mackay Memorial Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital

Registry information

Official study title

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

Acronym: T4222

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2022
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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