Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Device: GeneSearch™ Breast Lymph Node (BLN) Assay

• Registration Number: NCT00551278
• Lead Sponsor: Janssen Diagnostics, LLC

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-26
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-30
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	GeneSearch™ Breast Lymph Node (BLN) Assay	Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.	1 day

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States