NCT04568941

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Sentinel Lymph Node

Interventions

Type	Name	Description
BEHAVIORAL	Vacuum-Assisted Biopsy	Vacuum-Assisted Biopsy
BEHAVIORAL	Core Needle Biopsy	Core Needle Biopsy
BEHAVIORAL	Intraoperative Excisional Biopsy	Intraoperative Excisional Biopsy

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-05-01
• Completion: 2021-06-01
• First posted: 2020-09-29
• Last updated: 2020-10-27

Locations

1 site across 1 country: China