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

January 12, 2016 updated by: Applied Spectral Imaging Ltd.

Concordance Study of Her2 Expression Level in Breast Cancer Tissues

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women having breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GenASIs HiPath IHC #1
Expression of HER2 antibody. Semi-Quantitative value
GenASIs HiPath IHC #2
Expression of HER2 antibody. Semi-Quantitative value
GenASIs HiPath IHC #3
Expression of HER2 antibody. Semi-Quantitative value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVD study of HER2 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.

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
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
Time Frame: 1 Day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Spectral Imaging Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-HER2-IHC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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