Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial of Comparison of Tumor Biopsy Method of Preoperative Vacuum-Assisted, Core Needle Versus Intraoperative Excisional Biopsy for Sentinel Lymph Node Biopsy in Breast Cancer
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cance, and the identified number of sentinel lymph nodes determines its accuracy for axillary status. Retrospective study indicated that preoperative tumor biopsy results in more detected sentinel lymoh nodes. The clinical trail is designed to compare the effect of three tumor biopsy methods (preoperative vacuum-assisted biopsy, core needle biopsy, and intraoperative excisional biopsy) for sentinel lymph nodes.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | June 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - clinically lymph node negative breast cancer patients T1-T3 Exclusion Criteria: - history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients |
Country | Name | City | State |
---|---|---|---|
China | Zhiyong Yu | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong Cancer Hospital and Institute |
China,
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/s12957-020-019 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification rates of sentinel lymph node biopsy | Identification rate of SLNB between three groups | 1 year | |
Secondary | Identification numbers of sentinel lymph node biopsy | Identification numbers of SLNB between three groups | 1 year | |
Secondary | fase-negative rates of sentinel lymph node biopsy | fase-negative rates of SLNB between three groups | 1 year |
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