Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer (SOLO-1)

November 17, 2014 updated by: SOLTI Breast Cancer Research Group

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

701

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain
        • Vall d´Hebrón University Hospital
      • La Coruña, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
      • Las Palmas, Spain
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Lleida, Spain
        • Hospital Universitario Arnau de Vilanova
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Instituto Valenciano de Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At time of surgery
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)
At time of surgery
Specificity of the assay
Time Frame: At time of surgery
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
Time Frame: At time of surgery
Likelihood ratio of positive and negative results
At time of surgery
Positive predictive value at the cutoff of 10.000-15.000 copies/μL.
Time Frame: At time of surgery
At time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOLTI Breast Cancer Research Group

Collaborators

Sysmex America, Inc.

Investigators

  • Principal Investigator: Vicente Peg, MD, Vall d´Hebrón University Hospital
  • Study Chair: Isabel Rubio, MD, PhD, Vall d´Hebrón University Hospital
  • Study Chair: Martin Espinosa-Bravo, MD, PhD, Vall d´Hebrón University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (ESTIMATE)

August 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLTI-1113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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