Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue

Breast Cancer Clinical Trial

Official title:

Concordance Study of Her2 Expression Level in Breast Cancer Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654444
• Other study ID #: ASI-HER2-IHC
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: January 12, 2016
• Start date: May 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 quantification of protein expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

Description:

The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the 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 and older

Eligibility

Inclusion Criteria:

• Women having breast cancer aged 21 and up

• Borders of tumor nuclei are distinguishable

• Nuclei should have good integrity

• Background should not contain particles that interfere with the analysis

Exclusion Criteria:

• Slides that cannot be analyzed manually by Pathologist

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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 HER2 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.; The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%	1 Day	No
Primary	IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis	Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 & 1+, positive=2+ & 3+), if positive and negative average agreements will be at least 85%	1 Day	No