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Report for Clinical Trial NCT03300414

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Biologic Basis of Liver Cancer From Chronic Hepatitis B

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.

NCT03300414 Hepatocellular Carcinoma Hepatitis B, Chronic
MeSH:Hepatitis A Hepatitis B Hepatitis B, Chronic Carcinoma, Hepatocellular Liver Neoplasms Hepatitis
HPO:Hepatitis Hepatocellular carcinoma Neoplasm of the liver

1 Interventions

Name: One time blood draw

Description: Same as part 1
Type: Other
Group Labels: 1

Collection of blood specimen

Primary Outcomes

Description: In order to meet this aim, blood samples will be obtained from 10 consented subjects. The DNA extracted from these samples will be used as part of an ongoing study comparing viral sequences and gene expression profiles across Asian ethnic groups, we will analyze the same data comparing individuals with high and low HCC risk factors (i.e. the presence and absence of cirrhosis, high HBV viral load, men who have sex with men).

Measure: Associate viral sequences and host gene expression signatures with established HCC risk factors in Asian Americans.

Time: 1 year

Time Perspective: Prospective


There is one SNP


1 G1764A

Carcinogenesis 2008) Viral mutants including the A1762T/G1764A basal core promoter mutations and Pre-S region deletions are also associated with poor HCC outcomes and may be the result of selection by host immune responses and activation of endogenous cytidine deaminase by pro-inflammatory cytokines (e.g. --- G1764A ---

HPO Nodes