Identification and Semi -Quantification of ER/PR Proteins Expression

Study Overview
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Brief Summary
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The purpose of the study is the identification and quantification of proteins 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 ER/PR IHC stained samples.

Detailed Description
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The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the 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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Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Breast Cancer patient
* Procedure: Cancer patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women having breast cancer Exclusion Criteria: others

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Breast Cancer patients<br>Breast cancer patients | Procedure: Breast Cancer patient<br>* Samples<br>Procedure: Cancer patients<br>* Samples<br>|
| women with breast cancer<br>women with breast cancer | Procedure: Breast Cancer patient<br>* Samples<br>Procedure: Cancer patients<br>* Samples<br>|
| Cancer patients<br>Cancer patients | Procedure: Breast Cancer patient<br>* Samples<br>Procedure: Cancer patients<br>* Samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVD study of ER/PR 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. Accuracy of the study will be declared Success if Positive, Negative and Overall agreement with manual count of the ER & PR antibody at least 90%. | 1 Day | 
| IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis | Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of ER/PR are related to the average agreement for between runs, between days and between systems R&R part of the study will be declared Success if Positive and Negative average agreement 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), ER/PR, Breast cancer