Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04568941
• Other study ID #: ShandongCHI-13
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong Yu, PhD
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

OBJECTIVES:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Behavioral:
• Vacuum-Assisted Biopsy
Vacuum-Assisted Biopsy
• Core Needle Biopsy
Core Needle Biopsy
• Intraoperative Excisional Biopsy
Intraoperative Excisional Biopsy

Locations

Country	Name	City	State
China	Zhiyong Yu	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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

External Links

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