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

Sponsored by:	Veridex, LLC
Information provided by:	Veridex, LLC
ClinicalTrials.gov Identifier:	NCT00551278

Purpose

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

Condition	Intervention
Breast Cancer	Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol

Further study details as provided by Veridex, LLC:

Primary Outcome Measures:

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. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Samples of the tissue homogenate and extracted RNA will be retained and may be used for for further testing.

Estimated Enrollment:	150
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
1 Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.	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.

Groups/Cohorts

Assigned Interventions

1

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

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551278

Contacts

Contact: Maryanne Bowyer-Cherry, RN

317-274-0172

mbowyer@iupui.edu

Locations

United States, Indiana
Indiana University Hospital	Recruiting
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Veridex, LLC

Investigators

Principal Investigator:

Robert J. Goulet, MD

Indiana University Cancer Pavilion

More Information

Study Sponsor Website This link exits the ClinicalTrials.gov site

Responsible Party:	Ortho-Clinical Diagnostics ( Scott Adams, Clinical Science Manager )
Study ID Numbers:	BLN-US-IU-2006.00
Study First Received:	October 26, 2007
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00551278
Health Authority:	United States: Institutional Review Board

Keywords provided by Veridex, LLC:

sentinel lymph node
metastasis
molecular pathology

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009