Identification and Semi -Quantification of ER/PR Proteins Expression

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Hospital,,

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients

Description

Inclusion Criteria:

  • Women having breast cancer

Exclusion Criteria:

  • others

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
Intervention / Treatment
Breast Cancer patients
Breast cancer patients
Procedure: Breast Cancer patient
Samples
Procedure: Cancer patients
Samples
women with breast cancer
Procedure: Breast Cancer patient
Samples
Procedure: Cancer patients
Samples
Cancer patients
Procedure: Breast Cancer patient
Samples
Procedure: Cancer patients
Samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
1 Day
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%.
1 Day

Collaborators and Investigators

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

Sponsor

Applied Spectral Imaging Ltd.

Investigators

  • Study Chair: Sheila Dobin, Section Chief, Cytogenetics

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)

December 1, 2014

Study Registration Dates

First Submitted

June 26, 2014

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-ER/PR-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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