Identification and Semi-Quantification of Ki-67 Protein Expression Status

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Women with Breast Cancer

• Registration Number: NCT02654457
• Lead Sponsor: Applied Spectral Imaging Ltd.

Brief Summary

The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.

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 Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody 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 analysis and review of immunohistochemically stained histologic slides.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-05
• Study Completion: 2015-01
• Study First Submitted: 2015-02-05
• 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: 3

Inclusion Criteria

• Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.

Exclusion Criteria

• Slides that have lots of background that interfere with the analysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with Breast Cancer #2	Women with Breast Cancer	IVD Study
Women with Breast Cancer #3	Women with Breast Cancer	IVD Study
Women with Breast Cancer #1	Women with Breast Cancer	IVD Study

Primary Outcome Measures

Name	Time	Method
IVD study of Ki67 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 Ki67 antibody at least 85%.
IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis	1 Day	Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of Ki67 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 80%.