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| ID | Type | Description | Link |
|---|---|---|---|
| 11360/6199/1610/021554 | Other Grant/Funding Number | Ostrava University |
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| Name | Class |
|---|---|
| Silesian Hospital in Opava | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cN0 before and after neoadjuvant th., SLNB - negative, no AD | Experimental | Patients with cN0 before and after neoadjuvant therapy, SLNB - negative, without AD |
|
| cN0 before and after neoadjuvant th., SLNB - posit., AD | Experimental | Patients with cN0 before and after neoadjuvant therapy, SLNB - positive, AD (separated histological examination of lymph nodes in levels I and II) |
|
| cN1 before neoadj. th., cN0 after neoadj. th., SLNB, AD | Experimental | Patients with cN1 before neoadjuvant th., cN0 after neoadjuvant therapy, SLNB, AD (separated histological examination of lymph nodes in levels I and II) |
|
| cN1 after neoadjuvant therapy, SLNB, AD | Experimental | Patients with cN1 after neoadjuvant therapy, SLNB, AD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel lymph node biopsy (SLNB) | Procedure | Sentinel lymph node biopsy will be performed in the patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 24 months |
| Changes in the Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
Only women with a history of breast carcinoma will be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Žatecký, MD | Silesian Hospital in Opava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silesian Hospital in Opava | Opava | Moravian-Silesian Region | 746 01 | Czechia | ||
| University Hospital Ostrava |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23683750 | Background | Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15. | |
| 22847123 |
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The investigators have not decided to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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The patients will be divided into four groups, according to the stage of the disease prior to neoadjuvant therapy.
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No roles in the study will be marked.
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| Axillary dissection | Procedure | Axillary dissection procedure will be performed in the patients |
|
Changes in the Quality of Life will be assessed using the standardised World Health Organisation Quality of Life (WHOQOL) questionnaire. |
| 24 months |
| Overall Survival | The overall survival (in months, years) of the patients will be assessed. | 24 months |
| Disease-free Survival | The disease-free survival (in months, years) of the patients will be assessed. | 24 months |
| Progression-free Survival | The progression-free survival (in months, years) of the patients will be assessed. | 24 months |
| Ostrava-Poruba |
| Moravian-Silesian Region |
| 708 52 |
| Czechia |
| Background |
| Caudle AS, Hunt KK, Tucker SL, Hoffman K, Gainer SM, Lucci A, Kuerer HM, Meric-Bernstam F, Shah R, Babiera GV, Sahin AA, Mittendorf EA. American College of Surgeons Oncology Group (ACOSOG) Z0011: impact on surgeon practice patterns. Ann Surg Oncol. 2012 Oct;19(10):3144-51. doi: 10.1245/s10434-012-2531-z. Epub 2012 Jul 31. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |