Abbreviated Name

Liver Rapid Ref Set App: Norman (2012)

Lead Investigator

Norman, Gary L. — INOVA Diagnostics Inc.

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Srivastava, Sudhir — National Cancer Institute
• Norman, Gary L. — INOVA Diagnostics Inc.
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

We have developed a new and novel assay for the detection of Golgi protein 73 (GP73), also known as Golgi membrane protein 1 (Golm1) or Golgi phosphoprotein 2 (Golph2), in serum/plasma. The clinical question is to determine the clinical utility of gp73 antigen detection by the new assay for early hepatocullular carcinoma (HCC) diagnosis, for risk-assessment of patients at high risk for progression of their liver disease, and for prognosis.

Aims

The EDRN reference set will provide us with an opportunity to test the present version of the assay on a new, well-characterized cohort that has not been subjected to multiple freeze/thaw cycles.

Analytic Method

Since this assay will be submitted to the FDA for 510(k) clearance, we will want to test a training set prior to the blinded test set. Statistical analysis will be conducted at the DMCC.

Outcome

We have developed a new and novel assay for the detection of Golgi protein 73 (GP73), also known as Golgi membrane protein 1 (Golm1) or Golgi phosphoprotein 2 (Golph2), in serum/plasma. The clinical question is to determine the clinical utility of gp73 antigen detection by the new assay for early hepatocullular carcinoma (HCC) diagnosis, for risk-assessment of patients at high risk for progression of their liver disease, and for prognosis.

Publications

• No publications available at this time for this protocol.

Biomarkers

• GP73

Data Collections

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

 Team Project

Start Date

Jul 12 2012

Estimated Finish Date

Sep 12 2012

Finish Date

Sep 30 2012

Protocol ID

356

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