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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654457
• Other study ID #: ASI-Ki-67-IHC
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: January 12, 2016
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Applied Spectral Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 89 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Women with Breast Cancer
IVD Study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Applied Spectral Imaging Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No