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

NCT00551278 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2016-01-12

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Janssen Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Robert J. Goulet, MD · Indiana University Cancer Pavilion

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551278 on ClinicalTrials.gov