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

NCT ID: NCT02654444

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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GenASIs HiPath IHC #1

Expression of HER2 antibody. Semi-Quantitative value

No interventions assigned to this group

GenASIs HiPath IHC #2

Expression of HER2 antibody. Semi-Quantitative value

No interventions assigned to this group

GenASIs HiPath IHC #3

Expression of HER2 antibody. Semi-Quantitative value

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Applied Spectral Imaging Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ASI-HER2-IHC

Identifier Type: -

Identifier Source: org_study_id

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