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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 is a clinical trial that has completed, run by University of California, Davis. The registered enrollment target is 2 participants.

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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.

Interventions

  • OTHER One time blood draw

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2017-03-20
Est. Completion 2018-12-14

Sponsor

University of California, Davis

657 total trials

What the Registry Record Tells You About NCT03300414

The ClinicalTrials.gov registry entry for NCT03300414 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which One time blood draw is the first listed.

NCT03300414 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.