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The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated patients-combined localization | Experimental | In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation |
|
| Untreated patients-single localization | Active Comparator | In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wire-guided localization and marker clip localization | Procedure | Positioning guide wire and marker clip in the center of the lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| positive margin rate | It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Re-operation rate | the proportion of patients which have a positive margin and requires reoperation | up to 3 months after first operation |
| The proportion of breast-conserving surgery | It refers to the proportion of patients who have successfully undergone breast-conserving surgery. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Gong, doctor | Contact | 02034070499 | changgong282@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Wire-guided localization | Procedure | Positioning guide wire in the center of the lesion |
|
| up to 3 months after first operation |
| IDFS | Time from surgery to the first occurrence of local, distant disease recurrence, or death. | 2 years, 3 years, and 5 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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