Clinical trial · Observational
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
NCT00551278CI-TRIAL-00020502completedClinicalTrials.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 this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
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 |
|---|---|---|---|
| GeneSearch™ Breast Lymph Node (BLN) Assay | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
- interventionNames
- Device: GeneSearch™ Breast Lymph Node (BLN) Assay
Primary outcomes (1)
- measure
- The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
- timeFrame
- 1 month
Secondary outcomes (1)
- measure
- A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previous diagnosis of carcinoma of the breast * Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site * 18 years or older * Female or male, and * Able and willing to give consent to participate in the study Exclusion Criteria: * Patients taking part in other research studies that would interfere with their full participation in this study
References
Publications (0)
Data not yet available
No reference posted for this study.