Identification and Semi -Quantification of ER/PR Proteins Expression

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02654431

Enrollment

350

Registered

2016-01-13

Start date

2013-05-31

Completion date

2014-12-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Immunohistochemical (IHC), ER/PR, Breast cancer

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREBreast Cancer patient

Samples

PROCEDURECancer patients

Samples

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Women having breast cancer

Exclusion criteria

* others

Design outcomes

Primary

Measure	Time frame	Description
IVD study of ER/PR IHC samples: Accuracy of analysis	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%.
IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis	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%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026