Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue

Study Overview
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Brief Summary
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The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

Detailed Description
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The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Official Title
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Concordance Study of Her2 Expression Level in Breast Cancer Tissues

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women having breast cancer aged 21 and up Borders of tumor nuclei are distinguishable Nuclei should have good integrity Background should not contain particles that interfere with the analysis Exclusion Criteria: Slides that cannot be analyzed manually by Pathologist

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| GenASIs HiPath IHC #1<br>Expression of HER2 antibody. Semi-Quantitative value | |
| GenASIs HiPath IHC #2<br>Expression of HER2 antibody. Semi-Quantitative value | |
| GenASIs HiPath IHC #3<br>Expression of HER2 antibody. Semi-Quantitative value | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVD study of HER2 IHC samples: Accuracy of analysis | Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80% | 1 Day | 
| IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis | Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R&R part of the study will be declared Success based on the two-level HER2/neu outcome (negative=0 & 1+, positive=2+ & 3+), if positive and negative average agreements will be at least 85% | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunohistochemical (IHC), Her2/Neu, Breast cancer