- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654431
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
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Temple, Texas, United States, 76508
- Scott & White Hospital,,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women having breast cancer
Exclusion Criteria:
- others
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Breast Cancer patients
Breast cancer patients
|
Samples
Samples
|
women with breast cancer
|
Samples
Samples
|
Cancer patients
|
Samples
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
Sponsor
Investigators
- Study Chair: Sheila Dobin, Section Chief, Cytogenetics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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