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| Name | Class |
|---|---|
| Sysmex America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSNA | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Estimate the negative predictive value of the technique OSNA. | 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. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ROC curve that describes the assay | ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs | At time of surgery |
| Sensitivity of the assay |
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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:
Exclusion Criteria:
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Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay with a complete axillary lymph node dissection.
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| Name | Affiliation | Role |
|---|---|---|
| Vicente Peg, MD | Vall d´Hebron University Hospital | Principal Investigator |
| Isabel Rubio, MD, PhD | Vall d´Hebron University Hospital | Study Chair |
| Martin Espinosa-Bravo, MD, PhD | Vall d´Hebron University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Santiago de Compostela | A Coruña | Spain | ||||
| Hospital Universitario de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23576079 | Result | Peg 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. | |
| Result | Peg 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. |
| Label | URL |
|---|---|
| SOLTI Breast Cancer Research Group | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)
| At time of surgery |
| Specificity of the assay | Probability that OSNA in SLN is negative because there is no involvement of NSLN | At time of surgery |
| Likelihood ratio for the cutoff of 10,000-15,000 copies/uL | Likelihood ratio of positive and negative results | At time of surgery |
| Positive predictive value at the cutoff of 10.000-15.000 copies/μL. | At time of surgery |
| Barcelona |
| Spain |
| Vall d´Hebron University Hospital | Barcelona | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario de Salamanca | Salamanca | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | Spain |
| Instituto Valenciano de Oncología | Valencia | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |