NCT02654444

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

Concordance Study of Her2 Expression Level in Breast Cancer Tissues

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

Summary

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

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.

Conditions

• Breast Cancer

Timeline

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