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GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

NCT00595296 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 461

Last updated 2016-01-12

No results posted yet for this study

Summary

This post-approval study is designed to determine the performance of the FDA-approved GeneSearch™ BLN Assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more extensive histological evaluation when the assay is being used by clinicians to make surgical decisions on complete axillary dissections (ALND).

Conditions

Interventions

DEVICE

GeneSearch™ Breast Lymph Node (BLN) Assay

The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).

Sponsors & Collaborators

  • Janssen Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Scott U Adams, MS · Ortho-Clinical Diagnostics, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
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 NCT00595296 on ClinicalTrials.gov