Back to results

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

Primary Purpose

Breast Cancer, Sentinel Lymph Node

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Vacuum-Assisted Biopsy

Core Needle Biopsy

Intraoperative Excisional Biopsy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Zhiyong Yu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Preoperative Vacuum-Assisted Biopsy

Preoperative Core Needle Biopsy

Intraoperative Excisional Biopsy

Arm Description

Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.

Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.

The tumor was excised intraoperatively.

Outcomes

Primary Outcome Measures

Identification rates of sentinel lymph node biopsy

Identification rate of SLNB between three groups

Secondary Outcome Measures

Identification numbers of sentinel lymph node biopsy

Identification numbers of SLNB between three groups

fase-negative rates of sentinel lymph node biopsy

fase-negative rates of SLNB between three groups

Full Information

NCT ID

NCT04568941

First Posted

September 26, 2020

Last Updated

October 24, 2020

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT04568941

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2020 (Anticipated)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Sentinel Lymph Node

Keywords

Sentinel Lymph Node, vacuum-assisted biopsy, Core needle biopsy, Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preoperative Vacuum-Assisted Biopsy

Arm Type

Experimental

Arm Description

Preoperative vacuum-assisted biopsy was performed within 10 days before final surgery. The tumor were excised almost.

Arm Title

Preoperative Core Needle Biopsy

Arm Type

Experimental

Arm Description

Preoperative core needle biopsy was performed within 10 days before final surgery. The needle biopsy were performed with 3 needles.

Arm Title

Intraoperative Excisional Biopsy

Arm Type

Experimental

Arm Description

The tumor was excised intraoperatively.

Intervention Type

Behavioral

Intervention Name(s)

Vacuum-Assisted Biopsy

Intervention Description

Vacuum-Assisted Biopsy

Intervention Type

Behavioral

Intervention Name(s)

Core Needle Biopsy

Intervention Description

Core Needle Biopsy

Intervention Type

Behavioral

Intervention Name(s)

Intraoperative Excisional Biopsy

Intervention Description

Intraoperative Excisional Biopsy

Primary Outcome Measure Information:

Title

Identification rates of sentinel lymph node biopsy

Description

Identification rate of SLNB between three groups

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Identification numbers of sentinel lymph node biopsy

Description

Identification numbers of SLNB between three groups

Time Frame

1 year

Title

fase-negative rates of sentinel lymph node biopsy

Description

fase-negative rates of SLNB between three groups

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyong Yu, PhD

Phone

86-13355312277

drzhiyongyu@aliyun.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chao Li, MD

Phone

86-15665851082

lichao19890305@126.com

Facility Information:

Facility Name

Zhiyong Yu

City

Jinan

State/Province

Shandong

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiyong Yu, PhD

Phone

86053167626958

Ext

86053167626958

drzhiyongyu@aliyun.com

First Name & Middle Initial & Last Name & Degree

Chao Li, MD

Phone

86053167626958

Ext

86053167626958

lichao19890305@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32693797

Citation

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.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/32693797/

Description

Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs