Early Detection Research Network
Team Project

BBD Reference Set Application: Jeffery Marks-Duke (2015)

BBD Ref Set App: Marks (2015)
Feng, ZidingFred Hutchinson Cancer Research Center
KI-67, EZH2, PTGS2 (COX2), ALDH1, CDKN2A (p16), HYAL1, MMP1, CEACAM6, and TP53.
No design specified.
Breast and Gynecologic Cancers Research Group

We propose a pre-validation study for markers that could predict the likelihood of invasive breast cancer following a tissue diagnosis of benign breast pathology (any diagnosis that is less severe than carcinoma in situ). The study is designed to test the utility of a series of markers that were shown to have some predictive value by immunohistochemical staining in other cohorts. These markers include the proliferation associated antigen KI-67, EZH2, PTGS2 (COX2), ALDH1, CDKN2A (p16), HYAL1, MMP1, CEACAM6, and TP53. In addition, we propose analyzing two markers that comprise part of the DCIS Oncotype panel, GSTM1 and progesterone receptor (PR). The study will occur in two EDRN clinical validation center (CVC) laboratories, namely Duke and University of Kansas, and utilize specimens from Northwestern University and Geisinger Health System that have been identified and are either already sectioned or waiting to be sectioned. Results will be scored and returned to the DMCC to determine whether any of the markers or combinations of these markers may have sufficient value to proceed to a second stage validation with large numbers of samples from Geisenger Health Systems and the Henry Ford Hospital.

We propose that two of the highest value markers based on published data (KI-67 and EZH2) will be performed by both Duke and Kansas.
Our main BBD protocol argues that in order to be useful a biomarker should have a TPR/FPR ratio of at least 2.0, where TPR is the marker’s sensitivity and FPR is 1-specificity.

No datasets are currently associated with this protocol.

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