An observational study in Breast Cancer, sponsored by Janssen Diagnostics, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Janssen Diagnostics, LLC · Observational
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 80 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Janssen Diagnostics, LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
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Exclusion Criteria:
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.
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
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
The record gives a start of Oct 2007, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Janssen Diagnostics, LLC