Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- IVD study of ER/PR IHC samples: Accuracy of analysis
研究概览
简要总结
The purpose of the study is the identification and quantification of proteins 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 ER/PR IHC stained samples.
详细描述
The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies 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 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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women having breast cancer
排除标准
- 未提供
结局指标
主要结局
IVD study of ER/PR 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. Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the ER \& PR antibody at least 90%.
IVD study of ER/PR 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 ER/PR are related to the average agreement for between runs, between days and between systems R\&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 85%.
次要结局
未报告次要终点