Clinical trial · Observational
Biologic Basis of Liver Cancer From Chronic Hepatitis B
- 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)
The focus of the study is to identify viral factors and host immune responses that differentiate HBV-related HCC patients from HBV patients who have not progressed to HCC. To that end, the investigators will compare gene expression levels between HCC patients and non-HCC patients categorized into high and low risk profiles. The investigators will perform ANOVA to compare three groups (HCC, high risk, low risk). Multiple comparison corrections will be performed using Benjamini and Hochberg False Discovery Rate (FDR) with a 90% confidence that the discovery lists will contain no more than 5% false positives (FDR\<0.05) (PMID: 12584122, 11682119). A p-value \<0.05 is considered statistically significant using this multiple comparison correction approach. Post-hoc Student-Newman-Keuls or Tukey tests will be used following ANOVA for comparisons of HCC patients with high risk and low risk. If data are not normally distributed when log-transformed, then Kruskall-Wallis tests will be used. ANCOVA will be used to adjust for the effects of covariates, such as age, gender, and HBV genotype (B or C). Further, the investigators often use an additional 2-fold change criterion for significance because the investigators consider a fold change of this magnitude to be biologically significant. Hierarchical clustering analyses and principal component analyses will be used to visualize how well the genes separate the groups, or to discover new subgroups. For the analysis of SNVs, the exact binomial test will be performed and p-values will be adjusted by the Benjamini-Hochberg correction.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B, Chronic | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| One time blood draw | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Collection of blood specimen
- description
- Collection of blood specimen from patients will be performed during the course of routine medical care at UC Davis with no prospective follow up period. The duration anticipated to enroll all 10 study subjects will be 1 year. The estimated date for the investigator to complete analysis and publication is 2 years.
- interventionNames
- Other: One time blood draw
- label
- Liver Biopsy slides
- description
- Up to twenty (20) de-identified hepatocellular carcinoma (HCC) tissue sections on biopsy slides or frozen sections and associated information such as age, sex, race, ethnicity, treatment status, pathological diagnoses, and date of procedure will be obtained from UC Davis Cancer Center Biorepository (CCB) and outside tissue biobanks, including, but not limited to, Cooperative Human Tissue Network (CHTN). The duration anticipated to complete analysis and publication is 2 years.
Primary outcomes (1)
- measure
- Associate viral sequences and host gene expression signatures with established HCC risk factors in Asian Americans.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Asian Americans 2. Aged 18 years or older with a confirmed diagnosis of HCC and liver cancer from chronic hepatitis B. 3. The diagnosis of liver cancer can be made with by meeting radiologic criteria for HCC or liver histology obtained through liver biopsy. Exclusion Criteria: 1. Co-infection with hepatitis C virus (HCV) or HIV 2. Use of immunosuppressive medications 3. Inability to give informed consent 4. Prisoners 5. Pregnant women 6. Cognitively impaired individuals or inability to provide informed consent
References
Publications (0)
Data not yet available