Abbreviated Name

BBD Ref Set App: Marks (2015)

Lead Investigator

Marks, Jeffrey — Duke University Medical Center

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Godwin, Andrew K — University of Kansas Medical Center
• Marks, Jeffrey — Duke University Medical Center
• Zheng, Yingye — Fred Hutchinson Cancer Center

Abstract

No abstract availalbe.

Aims

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.

Analytic Method

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.

Outcome

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 Geisinger Health Systems and the Henry Ford Hospital.

Publications

• No publications available at this time for this protocol.

Biomarkers

• ALDH1A1
• CDKN2A (p16)
• CEACAM6
• EZH2
• GSTM1
• HYAL1
• MKI67
• MMP1
• PGR
• PTGS2
• TP53

Data Collections

• No data collections available at this time for this protocol.

 Team Project

Start Date

Mar 31 2015

Estimated Finish Date

Aug 5 2015

Protocol ID

402

Protocol Type

Reference Set

Fields of Research

• Proteomics

Collaborative Group

Breast and Gynecologic Cancers Research Group

Cancer Types

• Malignant neoplasm of breast