Identification and Semi -Quantification of ER/PR Proteins Expression

NCT ID: NCT02654431

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

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

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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Breast Cancer patients

Breast cancer patients

Breast Cancer patient

Intervention Type PROCEDURE

Samples

Cancer patients

Intervention Type PROCEDURE

Samples

women with breast cancer

women with breast cancer

Breast Cancer patient

Intervention Type PROCEDURE

Samples

Cancer patients

Intervention Type PROCEDURE

Samples

Cancer patients

Cancer patients

Breast Cancer patient

Intervention Type PROCEDURE

Samples

Cancer patients

Intervention Type PROCEDURE

Samples

Interventions

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Breast Cancer patient

Samples

Intervention Type PROCEDURE

Cancer patients

Samples

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women having breast cancer

Exclusion Criteria

* others
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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

Principal Investigators

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Sheila Dobin

Role: STUDY_CHAIR

Section Chief, Cytogenetics

Locations

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Scott & White Hospital,,

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ASI-ER/PR-IHC

Identifier Type: -

Identifier Source: org_study_id

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