Liver Full Reference Set Application: David Lubman - Univ of Michigan (2011)

Abbreviated Name

Liver Full Ref Set App: Lubman (2011)

Lead Investigator

Lubman, David — University of Michigan Medical School

Coordinating Investigator

Feng, Ziding — Fred Hutchinson Cancer Center

Involved Investigators

Abstact

Aims

hase 2 validation of glycoproteins that have passed Phase 1 blinded validation using ELISA kits based on target glycoproteins selected based on our previous work.

Analytic Method

The data for each sample for the ELISA assays will be sent to the Data Management and Coordinating Center(DMCC) of the EDRN for analysis. The DMCC has worked with us on analysis of the data in the 50:50 reference set of the phase 1 validation. They will continue to help us on blinding, randomization, study design, data analysis and interpretation for the validation study. They will also use similar methods to analyze the data in this phase 2 trial as used in the previous work. A logistic regression model was used to estimate the classification percentile values at different cutoff points for both single and combined markers. Based on empirical distributions of the resulting sensitivity and specificity, AUROC relevant summary indices can be computed by descriptive statistics and resampling processes. The performance of each marker was determined by generating a ROC curve and determining the AUROC and the optimal sensitivity and specificity for each marker and also the likelihood ratios. The area under the ROC (AUROC) curves were calculated and compared. In addition, they compared the results to that of the standard biomarker, AFP and studied how the new glycosylated markers might combine with AFP.

Biomarkers

Data Collections

No data collections available at this time for thie protocol

Team Project

Protocol ID

336

Protocol Type

Reference Set

Field of Research

Glycomics

Collaborative Group

G.I. and Other Associated Cancers Research Group

Cancer Types

Liver cell carcinoma

Phased Status