Skip to main content
OpenTrials
Completed

NCT Number: NCT02654457

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year–89 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Women with Breast Cancer

Procedure

IVD Study

Primary outcomes

  1. IVD study of Ki67 IHC samples: Accuracy of analysis

    Time frame: 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%.

  2. IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Applied Spectral Imaging Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 13, 2016
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.