Early Detection Research Network

Liver Rapid Reference Set Application: Hiro Yamada - Wako (2011)

Liver Rapid Ref Set App: Yamada (2011)
Yamada, HiroWako Diagnostics
Feng, ZidingFred Hutchinson Cancer Research Center
No design specified.
G.I. and Other Associated Cancers Research Group

Measure clinical effectiveness of AFP-L3 and DCP for early detection of HCC in patient samples collected prospectively during surveillance. However since such samples are not readily available in the USA the reference set samples are well characterized and studied, gaining access to these samples will allow Wako to quickly measure clinical effectiveness of AFP-L3 and DCP in detecting early HCC.

Effectively measure AFP-L3 and DCP for early detection of HCC.
Sensitivity and specificity of AFP, AFP-L3% and DCP assays on the uTASWako 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. For three single markers, i.e. AFP_wako (AFP from Wako), AFP_L3 and DCP), the data was analyzed by two steps: (1), the Receiver Operating Characteristic (ROC) curve was plotted to show the marker overall performance differences by the areas under the Curve (AUC)and their 95% confidence intervals (CI), they were contrasted with the AFP values from EDRN; and (2) these markers were compared with the standard AFP on the optimal cutoff values and their associated sensitivity and specificity; the underlying optimal estimation was basis on the maximum sum of se. and sp. To know combination potentials among these three single markers from Wako, the logistic regression model was then applied to judge if and how the two markers AFP_L3 and DCP could be combined with the values of AFP_W and the standard AFP. The marker values were transformed by their logarithm functions. These logarithm based marker values were regarded as the independent variables to be put into the logit models by the forward selection. The model based linear scores were then used as the combined marker indicators to do further data analysis for the combined markers in ROC performances.

No datasets are currently associated with this protocol.

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