Breast Cancer Clinical Trial
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Summary
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
Full Description
This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearchâ„¢ 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.
Eligibility Criteria
Inclusion Criteria:
Previous diagnosis of carcinoma of the breast
Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
18 years or older
Female or male, and
Able and willing to give consent to participate in the study
Exclusion Criteria:
Patients taking part in other research studies that would interfere with their full participation in this study
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States
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