Abbreviated Name

Liver Rapid Ref Set App: Qu (2011)

Lead Investigator

Qu, Kevin — Quest Diagnostics

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Srivastava, Sudhir — National Cancer Institute
• Qu, Kevin — Quest Diagnostics
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

We propose to evaluate the performance of a novel serum biomarker panel for early detection of hepatocellular carcinoma (HCC). This panel is based on markers from the ubiquitin-proteasome system (UPS) in combination with the existing known HCC biomarkers, namely, alpha-fetoprotein (AFP), AFP-L3%, and des-y-carboxy prothrombin (DCP). To this end, we applied multivariate logistic regression analysis to optimize this biomarker algorithm tool.

Aims

We propose to evaluate the performance of a novel serum biomarker panel for early detection of hepatocellular carcinoma (HCC).

Analytic Method

In the proposed study, we will not need a training set in addition to a blinded reference set. The HCC UPS model was selected from a working set that included patients with HCC (n=135), and CLD with cirrhosis (F3-4, n=148), with samples randomly assigned into 100 training sets and testing sets. The model was created using these training sets and evaluated in the testing sets by averaged error rates and area under the ROC (AUROC) curve analysis. The blinded reference set is designed to confirm the utility of the HCC UPS model. Our statisticians will perform all statistic analysis; Dr. Michael Walker, a professor at Stanford University, will monitor the statistical analysis. We will not need help from the EDRN if we do a larger Phase II validation study.

Comments

No comments available.

Outcome

The UPS team used the standard EDRN sample set of 49 cases and 50 controls to test the six of markers proposed for the early HCC detection, these markers included AFP, DCP, Proteasome (p), trypsin (Tr-L), Chymotorpson (Ch-L), and Caspase (Cas-L). Of the six biomarkers developed in the UPS team, only AFP_ups and DCP had similar performances to that of the standard AFP from EDRN. These two markers were also complementary each other to combine together for predicting the positive response in the HCC early detection.

Secure Outcome

No secure outcome available.

Publications

• No publications available at this time for this protocol.

Biomarkers

• AFP
• AFP-L3
• DCP

Data Collections

• No data collections available at this time for this protocol.

Start Date

Feb 28 2011

Estimated Finish Date

Jun 28 2011

Finish Date

Feb 28 2011

Protocol ID

329

Protocol Type

Reference Set

Fields of Research

• Proteomics

Collaborative Group

G.I. and Other Associated Cancers Research Group

Cancer Types

• Liver cell carcinoma

Phased Status

1