Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer
NCT ID: NCT05797454
Last Updated: 2024-07-03
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
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RECRUITING
NA
170 participants
INTERVENTIONAL
2023-02-17
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Untreated patients-combined localization
In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation
Wire-guided localization and marker clip localization
Positioning guide wire and marker clip in the center of the lesion
Untreated patients-single localization
In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation
Wire-guided localization
Positioning guide wire in the center of the lesion
Interventions
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Wire-guided localization and marker clip localization
Positioning guide wire and marker clip in the center of the lesion
Wire-guided localization
Positioning guide wire in the center of the lesion
Eligibility Criteria
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Inclusion Criteria
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
Exclusion Criteria
2. Breast deformities and other conditions that impact breast conservation success rate
3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
4. Pregnancy or lactation
5. Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
18 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Chang Gong
Clinical Professor
Locations
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYSKY-2023-129-01
Identifier Type: -
Identifier Source: org_study_id
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