Concordance Study of Her2 Expression Level in Breast Cancer Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- IVD study of HER2 IHC samples: Accuracy of analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Slides that cannot be analyzed manually by Pathologist
结局指标
主要结局
IVD study of HER2 IHC samples: Accuracy of analysis
时间窗: 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
时间窗: 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%
次要结局
未报告次要终点