Identification and Semi-Quantification of Ki-67 Protein Expression Status

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides. 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
-----------------
The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody 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 analysis and review of immunohistochemically stained histologic slides.

Official Title
-----------------
Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Women with Breast Cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity. Exclusion Criteria: Slides that have lots of background that interfere with the analysis

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with Breast Cancer #1<br>IVD Study | Procedure: Women with Breast Cancer<br>* IVD Study<br>|
| Women with Breast Cancer #2<br>IVD Study | Procedure: Women with Breast Cancer<br>* IVD Study<br>|
| Women with Breast Cancer #3<br>IVD Study | Procedure: Women with Breast Cancer<br>* IVD Study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVD study of Ki67 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 Ki67 antibody at least 85%. | 1 Day | 
| IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis | Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of Ki67 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 80%. | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ki-67, Immunohistochemical, Breast cancer, IHC