Clinical trial · Observational
Identification and Semi-Quantification of Ki-67 Protein Expression Status
Identification and Semi-Quantification of Ki-67 Protein Expression Status in Formalin Fixed, Paraffin-embedded Normal and Neoplastic Breast Tissue
NCT02654457CI-TRIAL-00020516completedClinicalTrials.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 semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides. 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
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Women with Breast Cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Women with Breast Cancer #1
- description
- IVD Study
- interventionNames
- Procedure: Women with Breast Cancer
- label
- Women with Breast Cancer #2
- description
- IVD Study
- interventionNames
- Procedure: Women with Breast Cancer
- label
- Women with Breast Cancer #3
- description
- IVD Study
- interventionNames
- Procedure: Women with Breast Cancer
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity. Exclusion Criteria: * Slides that have lots of background that interfere with the analysis
References
Publications (0)
Data not yet available
No reference posted for this study.