Sentinel Lymph Node Total Tumoral Load as a Predictor of Non Sentinel Node Involvement in Early Breast Cancer
NCT ID: NCT01669265
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
701 participants
OBSERVATIONAL
2012-06-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* CK19-negative breast tumor
* ALND with \<10 lymph nodes
* In situ carcinoma only
* Metastatic breast cancer at time of diagnosis
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sysmex America, Inc.
INDUSTRY
SOLTI Breast Cancer Research Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vicente Peg, MD
Role: PRINCIPAL_INVESTIGATOR
Vall d´Hebron University Hospital
Isabel Rubio, MD, PhD
Role: STUDY_CHAIR
Vall d´Hebron University Hospital
Martin Espinosa-Bravo, MD, PhD
Role: STUDY_CHAIR
Vall d´Hebron University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínico Universitario de Santiago de Compostela
A Coruña, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Vall d´Hebron University Hospital
Barcelona, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
SOLTI Breast Cancer Research Group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SOLTI-1113
Identifier Type: -
Identifier Source: org_study_id