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

Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Women with Breast Cancer

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 Type: Observational
• Enrollment (Actual): 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women having breast cancer aged 21 and up

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with Breast Cancer #1; IVD Study	Procedure: Women with Breast Cancer; IVD Study
Women with Breast Cancer #2; IVD Study	Procedure: Women with Breast Cancer; IVD Study
Women with Breast Cancer #3; IVD Study	Procedure: Women with Breast Cancer; IVD Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IVD study of Ki67 IHC samples: Accuracy of analysis	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%.	1 Day
IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis	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%.	1 Day

Collaborators and Investigators

• Sponsor: Applied Spectral Imaging Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 13, 2016

Study Record Updates

• Last Update Posted (Estimate): January 13, 2016
• Last Update Submitted That Met QC Criteria: January 12, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Breast cancer; Ki-67; Immunohistochemical; IHC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ASI-Ki-67-IHC