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 Contact

Study Locations

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.
Behavioral: Vacuum-Assisted Biopsy
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.
Behavioral: Core Needle Biopsy
Core Needle Biopsy
Experimental: Intraoperative Excisional Biopsy
The tumor was excised intraoperatively.
Behavioral: Intraoperative Excisional Biopsy
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.

Sponsor

Shandong Cancer Hospital and Institute

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.

General Publications

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

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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