Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

Detailed Description
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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.

Official Title
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GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol

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: Previous diagnosis of carcinoma of the breast Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site 18 years or older Female or male, and Able and willing to give consent to participate in the study Exclusion Criteria: Patients taking part in other research studies that would interfere with their full participation in this study

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>Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection. | Device: GeneSearch™ Breast Lymph Node (BLN) Assay<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab. |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastasis, sentinel lymph node, molecular pathology