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

NCT ID: NCT00551278

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-12-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

GeneSearch™ Breast Lymph Node (BLN) Assay

Intervention Type: DEVICE

For in vitro diagnostic use only.

The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.

Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required.

Interventions

GeneSearch™ Breast Lymph Node (BLN) Assay

For in vitro diagnostic use only.

The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.

Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Diagnostics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J. Goulet, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Cancer Pavilion

Locations

Indiana University Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

BLN-US-IU-2006.00

Identifier Type: -

Identifier Source: org_study_id