Abbreviated Name

Liver Rapid Ref Set App: Hemken (2015)

Lead Investigator

Hemken, Philip M — Abbott Diagnostics R&D

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Chan, Daniel — Johns Hopkins Medical Institutions
• Hemken, Philip M — Abbott Diagnostics R&D
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

No abstract availalbe.

Aims

The aim for this testing is to find a small panel of biomarkers (n=2-5) that can be tested on the Abbott ARCHITECT automated immunoassay platform for the early detection of hepatocellular carcinoma (HCC). This panel of biomarkers should perform significantly better than alpha-fetoprotein (AFP) alone based on multivariate statistical analysis. This testing of the EDRN reference set will help expedite the selection of a small panel of ARCHITECT biomarkers for the early detection of HCC. The panel of ARCHITECT biomarkers Abbott plans to test include: AFP, protein induced by vitamin K absence or antagonist-II (PIVKA-II), golgi protein 73 (GP73), hepatocellular growth factor (HGF), dipeptidyl peptidase 4 (DPP4) and DPP4/seprase (surface expressed protease) heterodimer hybrid. PIVKA-II is abnormal des-carboxylated prothrombin (DCP) present in vitamin K deficiency.

Analytic Method

The goal of this testing is to find a panel of biomarkers that significantly perform better than AFP alone for the early detection of HCC. The data analysis plan will reflect this goal by analyzing the data in univariate and multivariate manner using the statistical software JMP version 11 to generate dot plots and AUCs. Verification of data analysis will be performed by Abbott statisticians for both univariate and multivariate analysis. In parallel, statisticians from EDRN will analyze the data to see if both Abbott and EDRN analyses agree. Abbott will need to know the specimen key for this analysis in order to generate dot plots and AUCs. V. Future Plans If a small panel of ARCHITECT biomarkers shows promising performance, Abbott is definitely interested

Outcome

The aim for this testing is to find a small panel of biomarkers (n=2-5) that can be tested on the Abbott ARCHITECT automated immunoassay platform for the early detection of hepatocellular carcinoma (HCC). This panel of biomarkers should perform significantly better than alpha-fetoprotein (AFP) alone based on multivariate statistical analysis. This testing of the EDRN reference set will help expedite the selection of a small panel of ARCHITECT biomarkers for the early detection of HCC. The panel of ARCHITECT biomarkers Abbott plans to test include: AFP, protein induced by vitamin K absence or antagonist-II (PIVKA-II), golgi protein 73 (GP73), hepatocellular growth factor (HGF), dipeptidyl peptidase 4 (DPP4) and DPP4/seprase (surface expressed protease) heterodimer hybrid. PIVKA-II is abnormal des-carboxylated prothrombin (DCP) present in vitamin K deficiency.

Publications

• No publications available at this time for this protocol.

Biomarkers

• AFP
• DCP
• Fuc-HPX
• GP73

Data Collections

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

 Team Project

Start Date

Nov 25 2015

Estimated Finish Date

Nov 25 2016

Finish Date

Jun 28 2016

Protocol ID

415

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

2