Spots Global Cancer Trial Database for Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
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Trial Identification
Brief Title: Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Official Title: GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
Study ID: NCT00551278
Conditions
Interventions
Study Description
Brief Summary: The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Indiana University Hospital, Indianapolis, Indiana, United States
Contact Details
Name: Robert J. Goulet, MD
Affiliation: Indiana University Cancer Pavilion
Role: PRINCIPAL_INVESTIGATOR
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