Clinical trial · Observational
Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
NCT01669265CI-TRIAL-00016088SOLO-1completedClinicalTrials.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)
This is a retrospective, multicentric cohort study of patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection. The aim of the present study is to assess the intraoperative positive SLN total tumor load (TTL) obtained from the OSNA assay and to determine whether this TTL predicts non-SLN metastasis in patients with clinically node-negative early-stage breast cancer.
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 (1)
- label
- OSNA
- description
- Patient cases with cT1-3, N0 early breast cancer, who previously had intraoperative sentinel lymph node (SLN) evaluation by one-step nucleic acid amplification (OSNA) assay with a complete axillary dissection.
Primary outcomes (1)
- measure
- Estimate the negative predictive value of the technique OSNA.
- timeFrame
- At time of surgery
- description
- Estimate the negative predictive value of the technique OSNA for the cutoff point that maximizes (tentatively, 10,000 to 15,000 copies / uL) of axillary lymph node involvement in breast cancer early N0.
Secondary outcomes (5)
- measure
- ROC curve that describes the assay
- timeFrame
- At time of surgery
- description
- ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed invasive breast carcinoma * Stage T1-3,N0 evaluated by physical exam or imaging according to AJCC v.7 and best clinical local practices * Intraoperative evaluation of sentinel lymph node (SLN) by OSNA * Complete dissection of axillary lymph nodes after the evaluation of the SLNs by OSNA * Pathology report of the tumor and dissected lymph nodes that includes the following information: * primary tumor size (mm), tumor grade (Scarff-Bloom Richardson), estrogen receptor status * progesterone receptor status * HER2 status (ASCO/CAP guidelines) * Ki67 index * presence/absence of lymphovascular invasion * total number of sentinel and non-sentinel lymph nodes dissected during surgery * total number of positive and negative sentinel and non-sentinel lymph nodes, \*size of the metastasis in both sentinel and non-sentinel lymph nodes * total tumoral load in each sentinel lymph node, expressed as number of CK19 mRNA copies per microliter. Exclusion Criteria: * Patients who underwent neoadjuvant chemotherapy * CK19-negative breast tumor * ALND with \<10 lymph nodes * In situ carcinoma only * Metastatic breast cancer at time of diagnosis
References
Publications (2)
- RESULTPeg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11. PMID 23576079
- RESULTPeg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antúnez JJ, Salas MS, Sansano I, Delgado Sánchez JJ, Pinto W, Gozalbo F, Petit A, Rubio I. Intraoperative molecular analysis of sentinel lymph node as a new predictor of axillary status in early breast cancer. Poster session presented at: 35th Annual San Antonio Breast Cancer Symposium (SABCS); 2012 December 4th-8th; San Antonio, Texas, United States.