Identification and Semi -Quantification of ER/PR Proteins Expression

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Breast Cancer patient; Procedure: Cancer patients

• Registration Number: NCT02654431
• Lead Sponsor: Applied Spectral Imaging Ltd.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-05
• Study First Submitted: 2014-06-26
• Study Completion: 2014-12
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-12
• Last Update Submitted: 2016-01-12
• Study First Posted: 2016-01-13
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Women having breast cancer

Exclusion Criteria

• others

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients	Breast Cancer patient	Cancer patients
Breast Cancer patients	Cancer patients	Breast cancer patients
women with breast cancer	Breast Cancer patient	women with breast cancer
women with breast cancer	Cancer patients	women with breast cancer
Cancer patients	Cancer patients	Cancer patients
Breast Cancer patients	Breast Cancer patient	Breast cancer patients

Primary Outcome Measures

Name	Time	Method
IVD study of ER/PR IHC samples: Accuracy of analysis	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	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%.

Trial Locations

Locations (1)

Scott & White Hospital,,; 🇺🇸 Temple, Texas, United States