GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Study Overview
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Brief Summary
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This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.

Detailed Description
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Assay turn-around-time will be collected at sites that are using the GeneSearch BLN Assay for intraoperative testing of sentinel lymph nodes. The sites must be planning to use the assay result to guide the decision to complete an axillary lymph node dissection.

Official Title
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GeneSearch Breast Lymph Node (BLN) Assay Timing 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 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 subjects | 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 determine, under clinical use conditions, the assay turn-around-time (TAT) from the time of node removal to the report of the assay result to the surgeon. |  | 1 day | 
| To determine, under clinical use conditions, whether the assay result was or was not received in time ('time for decision' (TFD)) to make an intra-operative decision to proceed to further non-sentinel axillary lymph node dissection. |  | 1 day | 
| To collect data in relation to other surgical procedures during the SLND/breast surgery to determine if the assay TAT resulted in longer surgery time than would have occurred if the assay had not been used. |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node, Metastasis