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| ID | Type | Description | Link |
|---|---|---|---|
| 0120-178/2022/3 | Other Identifier | National Medical Ethics Committee of the Republic of Slovenia |
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The purpose of this study is to improve regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) who received neoadjuvant systemic treatment (NAST) by using ultrasound elastography.
This study aims to optimize regional surgical treatment in breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment (NAST). Ultrasound elastography will be validated as a method for identifying metastases or regressive posttreatment changes in removed axillary lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound Elastography Assessment | Experimental | Breast cancer patients with axillary lymph node metastases (cN+) after neoadjuvant systemic treatment undergo ultrasound elastography assessment to identify metastases or regressive changes in axillary lymph nodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Elastography | Device | Ultrasound elastography is used to assess axillary lymph nodes in order to identify metastases or regressive posttreatment changes after neoadjuvant systemic treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Residual Axillary Lymph Node Metastasis After NAST | Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of residual metastatic disease after neoadjuvant systemic treatment (NAST), using histopathological examination of excised lymph nodes as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), positive predictive value (PPV, %), and negative predictive value (NPV, %). | Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST). |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Intraoperative Ultrasound Elastography for Detection of Regressive Posttreatment Changes in Axillary Lymph Nodes After NAST | Diagnostic accuracy of intraoperative ultrasound elastography performed on excised axillary lymph nodes for detection of regressive posttreatment changes after neoadjuvant systemic treatment (NAST), using histopathological examination as the reference standard. Diagnostic performance will be reported as sensitivity (%), specificity (%), PPV (%), and NPV (%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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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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Single-group study evaluating ultrasound elastography for identification of metastases or regressive changes in removed axillary lymph nodes after neoadjuvant systemic treatment.
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| Intraoperative (during surgery) after completion of neoadjuvant systemic treatment (NAST). |
| D017437 |
| Skin and Connective Tissue Diseases |