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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women having breast cancer aged 21 and up
Borders of tumor nuclei are distinguishable
Nuclei should have good integrity
Background should not contain particles that interfere with the analysis

Exclusion criteria

Slides that cannot be analyzed manually by Pathologist

Treatment and study plan

Primary outcomes

IVD study of HER2 IHC samples: Accuracy of analysis

Time frame: 1 Day

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.

The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis

Time frame: 1 Day

Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 & 1+, positive=2+ & 3+), if positive and negative average agreements will be at least 85%

Sponsors and collaborators

Lead sponsor

Applied Spectral Imaging Ltd.

Industry

Registry information

Official study title

Concordance Study of Her2 Expression Level in Breast Cancer Tissues

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jan 13, 2016
Registry last updated: Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed