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Team Project

Breast Reference Set Application: Pinku Mukherjee-CanDiag (2014)

Mukherjee, PinkuCanDiag Inc
Feng, ZidingFred Hutchinson Cancer Research Center
Breast and Gynecologic Cancers Research

We would like to get all three sets of specimens, however, we are requesting Specimen Set 1 first: 30 subjects with invasive cancer and 30 subjects with benign disease without atypia.

Since we are in the process of working with a manufacturer to develop a kit using stable cell line production of our antibody, we would like to repeat an equivalent study with the new assay materials, which may influence the cutoff selection.
We recognize that all samples will be blinded to us with regards to case-control status. We will share the units/ml measured for each sample in Specimen Set 1. Based on data analysis done by DMCC, we would like to re-evaluate the cutoff using the approach we used in our study with Duke Samples described earlier as well as ROC curves. We are hoping that based on the performance of the first Specimen Set, we will be able to get the subsequent Specimen Sets 2 & 3 as well. Once testing is completed for all the Specimen Sets, we would like to calculate the following based on analysis done by DMCC: *Sensitivity = % of samples from women with Breast Cancer that are correctly identified *Specificity = % of samples from normal women or those with benign conditions that are correctly identified *Positive Predictive Value = True positives as a percent of all positives reported in the study *Negative Predictive Value = True negatives as a percent of all negatives reported in the study Correlation with Mammographic assessment categories (BI-RADS): For each BI-RADS category, we would like to: *Calculate true negatives as a percent of negatives reported for the BI-RADS category *Calculate true positives as a percent of positives reported for the BI-RADS category The above analysis by BI-RADS category will guide us in labeling considerations for an FDA submission.

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.

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