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

NCT05613621 | Active Not Recruiting DMC

• 1 other identifier: T4222
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; next-generation sequencing; precision medicine

Outcome Measures

Primary Outcomes (3)

• transcriptomic analysis of immune microenvironment

  using RNA-seq and multiplex immunofluorescence staining

  2 Years

• lipotoxic genotyping for SNPs

  lipotoxic genotyping for SNPs

  2 years

• clinical outcomes of MAFLD vs. non-MAFLD.

  clinical outcomes of MAFLD vs. non-MAFLD.

  2 years

Study Arms (2)

training cohort

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.

validation cohort

For the validation cohort, the clinical and pathological information will be obtained retrospectively by TCOG and will take 6 months to identify eligible patients for the 4 sub-groups listed above.

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

hepatocellular carcinoma patients

You may qualify if:

• 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.

You may not qualify if:

• Fibrolamellar HCC, sarcomatoid HCC, or a mixture of cholangiocarcinoma and HCC
• Inability to cooperate by providing a complete medical history.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Mackay Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (4)

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Cancer Center

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

next-generation sequencing

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Tsang-Wu Liu

  Taiwan Cooperative Oncology Group, NHRI

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TW (4)