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Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer


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Not Enrolling
Female
Breast Cancer

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Trial Information

Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Estimate the negative predictive value of the technique OSNA.

Outcome 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.

Outcome Time Frame:

At time of surgery

Safety Issue:

No

Principal Investigator

Vicente Peg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vall d´Hebron University Hospital

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

SOLTI-1113

NCT ID:

NCT01669265

Start Date:

June 2012

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • OSNA
  • sentinel lymph node
  • Breast Neoplasms

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