Biologic Basis of Liver Cancer From Chronic Hepatitis B

Completed

Conditions studied: Hepatocellular Carcinoma, Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT03300414

Run by

University of California, Davis

People needed

2

Starts

2017-03-20

Expected to finish

2018-12-14

Last updated by the study team

2019-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Asian Americans
• Aged 18 years or older with a confirmed diagnosis of HCC and liver cancer from chronic hepatitis B.
• The diagnosis of liver cancer can be made with by meeting radiologic criteria for HCC or liver histology obtained through liver biopsy.

You may not qualify if…

• Co-infection with hepatitis C virus (HCV) or HIV
• Use of immunosuppressive medications
• Inability to give informed consent
• Prisoners
• Pregnant women
• Cognitively impaired individuals or inability to provide informed consent

Where it is running

• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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