Clinical trial · Interventional
Intraoperative Molecular Diagnosis of Sentinel Lymph Node In Breast Cancer Patients
The Validation Study of the Intraoperative OSNA Molecular Assay
- 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)
One-step Nucleic Acid Amplification assay (the OSNA assay) (Sysmex, Kobe, Japan) was an objective molecular technique that combines node tissue homogenization and subsequent reverse-transcription loop-mediated isothermal amplification of CK-19 mRNA in a single quick step. In the study, the performance of the OSNA assay was compared with the present standard histological evaluation, and a comparative analysis of OSNA assay with Touch Imprint Cytology (TIC) was also been made.
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 |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The OSNA assay | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SLNs were tested by the OSNA assay Intraoperatively
- description
- SLNs were tested by the OSNA assay Intraoperatively
- interventionNames
- Device: The OSNA assay
Primary outcomes (1)
- measure
- The accuracy, sensitivity, specificity of the OSNA assay
- timeFrame
- 10 years
- description
- The accuracy, sensitivity, specificity of the OSNA assay
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: The breast cancer patients scheduled for SLNB. Exclusion Criteria: The patients who had undergone previous ipsilateral axillary surgery.
References
Publications (1)
- RESULTWang YS, Ou-yang T, Wu J, Liu YH, Cao XC, Sun X, Fu L, Liao N, Yang WT, Zhong WX, Lu AP. Comparative study of one-step nucleic acid amplification assay, frozen section, and touch imprint cytology for intraoperative assessment of breast sentinel lymph node in Chinese patients. Cancer Sci. 2012 Nov;103(11):1989-93. doi: 10.1111/cas.12001. Epub 2012 Oct 18. PMID 22924886