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NCT Number: NCT01669265

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Clínico Universitario de Santiago de Compostela, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Estimate the negative predictive value of the technique OSNA.

    Time frame: At time of surgery

    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

  1. ROC curve that describes the assay

    Time frame: At time of surgery

    ROC curve (Receiver Operating Characteristic) from the true and false positives and negatives of OSNA test for different cutoffs

  2. Sensitivity of the assay

    Time frame: At time of surgery

    Probability that OSNA in sentinel lymph nodes (SLN) is positive given that there is involvement of non-sentinel lymph nodes (NSLN)

  3. Specificity of the assay

    Time frame: At time of surgery

    Probability that OSNA in SLN is negative because there is no involvement of NSLN

  4. Likelihood ratio for the cutoff of 10,000-15,000 copies/uL

    Time frame: At time of surgery

    Likelihood ratio of positive and negative results

  5. Positive predictive value at the cutoff of 10.000-15.000 copies/μL.

    Time frame: At time of surgery

Sponsors and collaborators

Lead sponsor

SOLTI Breast Cancer Research Group

Other

Collaborators

  • Sysmex America, Inc.

Registry information

Acronym: SOLO-1

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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