GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
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).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study|
- To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- To estimate the positive predictive value (PPV) of the GeneSearch™ BLN Assay as measured against histology that is as accurate as possible in assessing whether a SLN is truly positive. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Samples of the lymph node tissue homogenate and RNA extract are collected if the subject gives permission via the informed consent form.
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||July 2010|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
All eligible patients.
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).
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.
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, District of Columbia|
|Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Morton Plant Hospital|
|Clearwater, Florida, United States, 33756|
|St. Anthony's Hospital|
|St. Petersburg, Florida, United States, 33705|
|United States, Georgia|
|Georgia Esoteric and Molecular Labs, LLC|
|Augusta, Georgia, United States, 30912|
|United States, Mississippi|
|Flowood, Mississippi, United States, 39232|
|Study Director:||Scott U Adams, MS||Ortho-Clinical Diagnostics|