Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue
Concordance Study of Her2 Expression Level in Breast Cancer Tissues
1 other identifier
observational
3
0 countries
N/A
Brief Summary
The purpose of the study is the identification and quantification of protein 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 her2 immunohistochemical (IHC) stained samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2013
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
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedJanuary 13, 2016
January 1, 2016
1 year
February 5, 2015
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
IVD study of HER2 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. The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%
1 Day
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R\&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 \& 1+, positive=2+ \& 3+), if positive and negative average agreements will be at least 85%
1 Day
Study Arms (3)
GenASIs HiPath IHC #1
Expression of HER2 antibody. Semi-Quantitative value
GenASIs HiPath IHC #2
Expression of HER2 antibody. Semi-Quantitative value
GenASIs HiPath IHC #3
Expression of HER2 antibody. Semi-Quantitative value
Eligibility Criteria
Women having breast cancer
You may qualify if:
- Women having breast cancer aged 21 and up
- Borders of tumor nuclei are distinguishable
- Nuclei should have good integrity
- Background should not contain particles that interfere with the analysis
You may not qualify if:
- Slides that cannot be analyzed manually by Pathologist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2015
First Posted
January 13, 2016
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
January 1, 2015
Last Updated
January 13, 2016
Record last verified: 2016-01