Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer (SOLO-1)
This study has been completed.
Sponsor:
SOLTI Breast Cancer Research Group
Collaborator:
Sysmex America, Inc.
Information provided by (Responsible Party):
SOLTI Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT01669265
First received: May 24, 2012
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition |
|---|
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Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer |
Resource links provided by NLM:
Further study details as provided by SOLTI Breast Cancer Research Group:
Primary Outcome Measures:
- Estimate the negative predictive value of the technique OSNA. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]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 Outcome Measures:
- ROC curve that describes the assay [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs
- Sensitivity of the assay [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)
- Specificity of the assay [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]Probability that OSNA in SLN is negative because there is no involvement of NSLN
- Likelihood ratio for the cutoff of 10,000-15,000 copies/uL [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]Likelihood ratio of positive and negative results
- Positive predictive value at the cutoff of 10.000-15.000 copies/μL. [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
| Enrollment: | 701 |
| Study Start Date: | June 2012 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with cT1-3, N0 breast cancer, who had intraoperative SLN evaluation by OSNA assay with a complete axillary lymph node dissection.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669265
Locations
| Spain | |
| Vall d´Hebron University Hospital | |
| Barcelona, Spain | |
| Hospital Universitario de Bellvitge | |
| Barcelona, Spain | |
| Hospital Clínico Universitario de Santiago de Compostela | |
| La Coruña, 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 | |
Sponsors and Collaborators
SOLTI Breast Cancer Research Group
Sysmex America, Inc.
Investigators
| Principal Investigator: | Vicente Peg, MD | Vall d´Hebron University Hospital |
| Study Chair: | Isabel Rubio, MD | Vall d´Hebron University Hospital |
| Study Chair: | Martin Espinosa, MD | Vall d´Hebron University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | SOLTI Breast Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT01669265 History of Changes |
| Other Study ID Numbers: | SOLTI-1113 |
| Study First Received: | May 24, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by SOLTI Breast Cancer Research Group:
|
Breast cancer OSNA sentinel lymph node |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013