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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Breast Cancer

Treatments: Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT00551278

BLN-US-IU-2006.00

Details and patient eligibility

About

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 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

1

Description:

Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Treatment:

Device: GeneSearch™ Breast Lymph Node (BLN) Assay