Liver Full Reference Set Application: Hiro Yamada - Wako (2011)
- Abbreviated Name
- Liver Full Ref Set App:Yamada (2011)
- Lead Investigator
- Yamada, Hiro — Wako Diagnostics
- Coordinating Investigator
- Zheng, Yingye — Fred Hutchinson Cancer Center
- Involved Investigators
Abstract
No abstract availalbe.
Aims
The specific aim of the proposal is to determine usefulness of the HCC biomarkers in early detection.
Analytic Method
Sensitivity and specificity of AFP, AFP-L3 and DCP assays on the μTASWako i30 will be calculated for the patients using several cutoff values (5%, 7%, 10% etc). Sensitivity by tumor characteristics (stage, size and number) will be evaluated, if the clinical information on the patient characteristics is available.
Outcome
Wako has received new 510(k) clearance for Lens culinaris agglutinin-reactive fraction of alpha-fetoprotein (AFP-L3) and Des-gamma-carboxy prothrombin (DCP) tests on an innovative μTASWako i30 analyzer from FDA. The AFP-L3 and DCP assayed on an older platform LiBASys have been cleared with indication of use for risk assessment of hepatocellular carcinoma (HCC) in patient at risk for the liver malignancy. Wako believes that early detection of HCC is critical for improving HCC patient outcome. Therefore, Wako is currently seeking collaborative opportunities to retrospectively measure clinical samples using the AFP-L3 and DCP for further determining of effectiveness of the HCC biomarkers in early detection which are collected prospectively during HCC surveillance. The Reference Sample Set in the EDRN biorepository are well characterized and studied. Access to these samples would allow Wako to quickly determine the clinical effectiveness of AFP-L3 and DCP in detecting early HCC
Publications
- No publications available at this time for this protocol.
Biomarkers
Data Collections
- No data collections available at this time for this protocol.
Team Project
- Start Date
- Jul 20 2011
- Estimated Finish Date
- Oct 20 2011
- Finish Date
- Nov 30 2011
- Protocol ID
- 334
- 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