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

NCT01669265 | Completed

• 1 other identifier: SOLTI-1113
• Study Type: observational
• Target: 701
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; OSNA; sentinel lymph node

Outcome Measures

Primary Outcomes (1)

• Estimate the negative predictive value of the technique OSNA.

  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 Outcomes (5)

• ROC curve that describes the assay

  At time of surgery

• Sensitivity of the assay

  At time of surgery

• Specificity of the assay

  At time of surgery

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

  At time of surgery

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

  At time of surgery

Study Arms (1)

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 Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead
• Sysmex America, Inc.: collaborator

Study Sites (9)

Hospital Clínico Universitario de Santiago de Compostela

A Coruña, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Vall d´Hebron University Hospital

Barcelona, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas, Spain

Location

Hospital Universitario Arnau de Vilanova

Lleida, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, Spain

Location

Instituto Valenciano de Oncología

Valencia, Spain

Location

Related Publications (2)

• Peg V, Espinosa-Bravo M, Vieites B, Vilardell F, Antunez JR, de Salas MS, Delgado-Sanchez JJ, Pinto W, Gozalbo F, Petit A, Sansano I, Del Mar Tellez M, Rubio IT. Intraoperative molecular analysis of total tumor load in sentinel lymph node: a new predictor of axillary status in early breast cancer patients. Breast Cancer Res Treat. 2013 May;139(1):87-93. doi: 10.1007/s10549-013-2524-z. Epub 2013 Apr 11.

  PMID: 23576079 RESULT

• 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.

  RESULT

Related Links

• SOLTI Breast Cancer Research Group

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Vicente Peg, MD

  Vall d´Hebron University Hospital

  PRINCIPAL INVESTIGATOR

• Isabel Rubio, MD, PhD

  Vall d´Hebron University Hospital

  STUDY CHAIR

• Martin Espinosa-Bravo, MD, PhD

  Vall d´Hebron University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: August 20, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

ES (9)