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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02654457

Enrollment

Registered

2016-01-13

Start date

2013-12-31

Completion date

2015-01-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Immunohistochemical, Ki-67, Breast cancer, IHC

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.

Interventions

PROCEDUREWomen with Breast Cancer

IVD Study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 89 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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%.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026