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Completed

NCT Number: NCT02654431

Identification and Semi -Quantification of ER/PR Proteins Expression

The purpose of the study is the identification and quantification of proteins 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 ER/PR IHC stained samples.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Scott & White Hospital,,

Temple, Texas, 76508, United States

About this study

The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies 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 review of immunohistochemically stained histologic slides.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women having breast cancer

Exclusion criteria

  • others

Treatment and study plan

Breast Cancer patient

Procedure

Samples

Cancer patients

Procedure

Samples

Primary outcomes

  1. IVD study of ER/PR 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.

    Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the ER & PR antibody at least 90%.

  2. IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis

    Time frame: 1 Day

    Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of ER/PR 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 85%.

Sponsors and collaborators

Lead sponsor

Applied Spectral Imaging Ltd.

Industry

Registry information

Official study title

Identification and Semi -Quantification of ER/PR Proteins Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Tissue

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2016
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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