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

Breast Cancer Clinical Trial

Official title:

GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551278
• Other study ID #: BLN-US-IU-2006.00
• Status: Completed
• Phase: N/A
• First received: October 26, 2007
• Last updated: January 11, 2016
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Janssen Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.		1 day	No

External Links

•   Study Sponsor Website