Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast Cancer
October 24, 2020 updated by: Zhiyong Yu, Shandong Cancer Hospital and Institute
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China
- Zhiyong Yu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Preoperative Vacuum-Assisted Biopsy
Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery.
The tumor were excised almost.
|
Vacuum-Assisted Biopsy
|
|
Experimental: 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
|
|
Experimental: Intraoperative Excisional Biopsy
The tumor was excised intraoperatively.
|
Intraoperative Excisional Biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification rates of sentinel lymph node biopsy
Time Frame: 1 year
|
Identification rate of SLNB between three groups
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification numbers of sentinel lymph node biopsy
Time Frame: 1 year
|
Identification numbers of SLNB between three groups
|
1 year
|
|
fase-negative rates of sentinel lymph node biopsy
Time Frame: 1 year
|
fase-negative rates of SLNB between three groups
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
September 26, 2020
First Submitted That Met QC Criteria
September 26, 2020
First Posted (Actual)
September 29, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 24, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShandongCHI-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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