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

Status Terminated

Clinical Trial 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).

Clinical Trial Description

The primary objective of this clinical study is to gather data to estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced, i.e., routine H&E histology of sentinel lymph node(s) (SLN) and, when available, routine histology of non-sentinel axillary lymph nodes (ALN). This study will provide information on the assay that will augment the performance data gained in pre-market validation studies. In addition, with the assay being used for ALND decision-making, the metastatic status of the non-sentinel axillary nodes can be taken into account in the performance measures, i.e., if the patient's sentinel or non-sentinel nodes are histologically positive, the patient will be considered positive for the primary comparison to the assay results. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Breast Cancer

Clinical Trial Details

NCT number	NCT00595296
Study type	Observational
Source	Janssen Diagnostics, LLC
Contact
Status	Terminated
Phase	N/A
Start date	December 2007
Completion date	December 2009

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