Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer
NCT ID: NCT04568941
Last Updated: 2020-10-27
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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UNKNOWN
NA
600 participants
INTERVENTIONAL
2020-11-01
2021-06-01
Brief Summary
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Detailed Description
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Compare the identification rate of sentinel lymph node in breast cancer patients with different tumor biopsy methods.
Evaluate the false-negative rates of sentinel lymph nodes in patients with different tumor biopsy methods.
OUTLINE:
The patients were randomly divided into three group, vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy. Preoperative vacuum-assisted biopsy and core needle biopsy were performed in 10 days before the final surgery. All patients received dual tracer (radiolabeled colloid and blue dye) guided SLNB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Preoperative Vacuum-Assisted Biopsy
Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.
Vacuum-Assisted Biopsy
Vacuum-Assisted Biopsy
Preoperative Core Needle Biopsy
Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.
Core Needle Biopsy
Core Needle Biopsy
Intraoperative Excisional Biopsy
The tumor was excised intraoperatively.
Intraoperative Excisional Biopsy
Intraoperative Excisional Biopsy
Interventions
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Vacuum-Assisted Biopsy
Vacuum-Assisted Biopsy
Core Needle Biopsy
Core Needle Biopsy
Intraoperative Excisional Biopsy
Intraoperative Excisional Biopsy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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Shandong Cancer Hospital and Institute
OTHER
Responsible Party
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Zhiyong Yu
Zhiyong Yu
Locations
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Zhiyong Yu
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yuan C, Wang X, Liu Z, Li C, Bian M, Shan J, Song X, Yu Z, Yu J. Preoperative tumor biopsy results in more detected sentinel nodes than intraoperative biopsy in breast cancer patients. World J Surg Oncol. 2020 Jul 21;18(1):178. doi: 10.1186/s12957-020-01942-4.
Related Links
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Related Info
Other Identifiers
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ShandongCHI-13
Identifier Type: -
Identifier Source: org_study_id