Clinical trial · Observational
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
NCT05613621CI-TRIAL-00093690T4222active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project will clarify the potential interaction between HBV infection and steatosis, and their impact on genetic alterations and tumor immune microenvironment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- training cohort
- description
- 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.
- label
- validation cohort
- description
- 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.
Primary outcomes (3)
- measure
- transcriptomic analysis of immune microenvironment
- timeFrame
- 2 Years
- description
- using RNA-seq and multiplex immunofluorescence staining
- measure
- lipotoxic genotyping for SNPs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.