Identification and Semi -Quantification of ER/PR Proteins Expression
1 other identifier
observational
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedJanuary 13, 2016
January 1, 2016
1 year
June 26, 2014
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
IVD study of ER/PR IHC samples: Accuracy of analysis
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
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
Study Arms (3)
Breast Cancer patients
Breast cancer patients
women with breast cancer
women with breast cancer
Cancer patients
Cancer patients
Interventions
Eligibility Criteria
Breast cancer patients
You may qualify if:
- Women having breast cancer
You may not qualify if:
- others
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scott & White Hospital,,
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sheila Dobin
Section Chief, Cytogenetics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2014
First Posted
January 13, 2016
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
December 1, 2014
Last Updated
January 13, 2016
Record last verified: 2016-01