NCT02654457

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Applied Spectral Imaging Ltd. · Industry
• Sex: Female
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Women with Breast Cancer	IVD Study

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-05-01
• Completion: 2015-01-01
• First posted: 2016-01-13
• Last updated: 2016-01-13