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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

• NCT number: NCT02654457
• Study type: Observational
• Source: Applied Spectral Imaging Ltd.
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Completion date: January 2015