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
1 other identifier
interventional
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Nov 2020
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 27, 2020
October 1, 2020
6 months
September 26, 2020
October 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification rates of sentinel lymph node biopsy
Identification rate of SLNB between three groups
1 year
Secondary Outcomes (2)
Identification numbers of sentinel lymph node biopsy
1 year
fase-negative rates of sentinel lymph node biopsy
1 year
Study Arms (3)
Preoperative Vacuum-Assisted Biopsy
EXPERIMENTALPreoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.
Preoperative Core Needle Biopsy
EXPERIMENTALPreoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.
Intraoperative Excisional Biopsy
EXPERIMENTALThe tumor was excised intraoperatively.
Interventions
Intraoperative Excisional Biopsy
Eligibility Criteria
You may qualify if:
- clinically lymph node negative breast cancer patients T1-T3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhiyong Yu
Jinan, Shandong, China
Related 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/s12957-020-01942-4.
PMID: 32693797RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Zhiyong Yu
Study Record Dates
First Submitted
September 26, 2020
First Posted
September 29, 2020
Study Start
November 1, 2020
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share