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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: GeneSearch™ Breast Lymph Node (BLN) Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-operatively established diagnosis of invasive carcinoma of the breast Scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a decision for an axillary lymph node dissection 18 years of age or older Female or male Willing and able to give informed consent to participate in the study Exclusion Criteria: Previous diagnosis of lymphoma Subjects participating in other research studies that would interfere with their full participation in this study Patients and/or conditions with 'interfering substances' as listed in the IFU. Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All eligible patients. | Device: GeneSearch™ Breast Lymph Node (BLN) Assay<br>* 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).<br>* Other names: GeneSearch™ BLN Assay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 week | 
| To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases. |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BreastCancer, Sentinel Lymph Nodes, Metastasis