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NCT03300414 · ClinicalTrials.gov registry record
Biologic Basis of Liver Cancer From Chronic Hepatitis B
A clinical trial, sponsored by University of California, Davis.
- Completed
- Registry status
- 2
- Enrollment target
NCT03300414: Completed study, sponsored by University of California, Davis.
NCT03300414 is a clinical trial that has completed, run by University of California, Davis. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03300414 has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- 2 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- OTHER One time blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2018-12-14 |
What the finished NCT03300414 record still lists
NCT03300414 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which One time blood draw is the first listed.
NCT03300414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03300414 about?
NCT03300414 is a clinical study titled "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 hi...
What is the current status of trial NCT03300414?
This trial is currently completed. The enrollment target is 2 participants. The study started on 2017-03-20. Estimated completion is 2018-12-14.
What interventions are being tested in trial NCT03300414?
The interventions under investigation include: One time blood draw (OTHER).
Who is sponsoring clinical trial NCT03300414?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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