NCT04156841

Brief Summary

Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 8, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 29, 2019

Last Update Submit

November 5, 2019

Conditions

Breast CancerSentinel Lymph Node

Outcome Measures

Primary Outcomes (3)

  • the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China

    the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients

    2020-12-31

  • the positive rate of SLNs in patients with early stage breast cancer in China

    SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB

    2020-12-31

  • the number of resected SLNs in patients with early stage breast cancer in China

    the average number of resected SLNB will be calculated

    2020-12-31

Secondary Outcomes (1)

  • incidence of infection events after SLNB in patients with early stage breast cancer in China

    2021-12-31

Study Arms (4)

performed SLNB using a single mapping agent

Diagnostic Test: mapping agent

performed SLNB by combination of blue dye and radiotracer

Diagnostic Test: mapping agent

underwent SLN surgery receiving neoadjuvant chemotherapy

Procedure: neoadjuvant chemotherapy

underwent SLN surgery not receiving neoadjuvant chemotherapy

Procedure: neoadjuvant chemotherapy

Interventions

mapping agentDIAGNOSTIC_TEST

according to different tracer methods, patients are divided into the implementation of a single mapping agent and implementation of combination of blue dye and radiotracer agent.

performed SLNB by combination of blue dye and radiotracerperformed SLNB using a single mapping agent
neoadjuvant chemotherapyPROCEDURE

Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.

underwent SLN surgery not receiving neoadjuvant chemotherapyunderwent SLN surgery receiving neoadjuvant chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018

You may qualify if:

  • breast cancer confirmed by fine needle aspiration or biopsy
  • SLNB with or without axillary lymph node dissection
  • receiving conventional systematic treatment or regional treatment
  • complete medical record.

You may not qualify if:

  • IV stage breast cancer
  • combined with secondary invasive malignant tumor
  • diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months
  • difficulty breathing at rest or need oxygen therapy
  • severe infection
  • uncontrolled diabetes
  • serious psychological or mental disorders
  • poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Juliang Zhang

CONTACT

029-84775271ycj617655094@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2019

First Posted

November 8, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

November 8, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)