An interventional study of Sentinel lymph node biopsy (SLNB) and Axillary dissection in Breast Cancer, sponsored by University Hospital Ostrava. Completed at 2 sites in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic
The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.
The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 61 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD
Procedure: Sentinel lymph node biopsy (SLNB)
Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II)
Procedure: Sentinel lymph node biopsy (SLNB) · Procedure: Axillary dissection
Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II)
Procedure: Sentinel lymph node biopsy (SLNB) · Procedure: Axillary dissection
Patients with cN1 after neoadjuvant therapy, SLNB, AD.
Procedure: Sentinel lymph node biopsy (SLNB) · Procedure: Axillary dissection
Sentinel lymph node biopsy will be performed in the patients
Axillary dissection procedure will be performed in the patients
Clear indications for SLNB or axillary dissection
Clear indications for SLNB or axillary dissection (AD) in women with breast carcinoma after neoadjuvant therapy using false-negativity rate of SLNB. False-negativity rate of SLNB under 10% is acceptable for avoiding AD.
Time frame: 24 months
Morbidity
Morbidity after SLNB and AD will be assessed by check-ups provided by clinicians. The result will be the percentage of patients which suffer from some complications after SLNB or AD. Common morbidity rate after AD is 20%, after SLNB 1-2%.
Time frame: 24 months
Changes in the Quality of Life
Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire.
Time frame: 24 months
Overall Survival
The overall survival (in months, years) of the patients will be assessed.
Time frame: 24 months
Disease-free Survival
The disease-free survival (in months, years) of the patients will be assessed.
Time frame: 24 months
Progression-free Survival
The progression-free survival (in months, years) of the patients will be assessed.
Time frame: 24 months
Plan to share: Undecided — The investigators have not decided to make individual participant data available to other researchers.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University Hospital Ostrava