GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
This study will determine the sensitivity, specificity, negative predictive value, and
positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its
performance to that of the current methods -- permanent section Hematoxylin and Eosin (H&E)
staining with IHC. Additional marker testing using probes associated with nodal metastases
may be used in the assay performance calculations. The observed performance measures will be
compared to those obtained in the larger U.S. registration trial to show that there are no
differences in the assay's performance.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
1 month
No
Robert J. Goulet, MD
Principal Investigator
Indiana University Cancer Pavilion
United States: Institutional Review Board
BLN-US-IU-2006.00
NCT00551278
October 2007
December 2009
Name | Location |
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Indiana University Hospital | Indianapolis, Indiana 46202 |