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:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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.

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 July 20, 2014