Clinical trial · Observational
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
NCT02654444CI-TRIAL-00020513completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- GenASIs HiPath IHC #1
- description
- Expression of HER2 antibody. Semi-Quantitative value
- label
- GenASIs HiPath IHC #2
- description
- Expression of HER2 antibody. Semi-Quantitative value
- label
- GenASIs HiPath IHC #3
- description
- Expression of HER2 antibody. Semi-Quantitative value
Primary outcomes (2)
- measure
- IVD study of HER2 IHC samples: Accuracy of analysis
- timeFrame
- 1 Day
- description
- 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%
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Slides that cannot be analyzed manually by Pathologist
References
Publications (0)
Data not yet available
No reference posted for this study.