Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

November 5, 2019 updated by: Xijing Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

21000

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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
performed SLNB using a single mapping agent
Diagnostic test: mapping agent
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 radiotracer
Diagnostic test: mapping agent
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.
underwent SLN surgery receiving neoadjuvant chemotherapy
Procedure: neoadjuvant chemotherapy
Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.
underwent SLN surgery not receiving neoadjuvant chemotherapy
Procedure: neoadjuvant chemotherapy
Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China
Time Frame: 2020-12-31
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
Time Frame: 2020-12-31
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
Time Frame: 2020-12-31
the average number of resected SLNB will be calculated
2020-12-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of infection events after SLNB in patients with early stage breast cancer in China
Time Frame: 2021-12-31
incidence of infection events is the number of patients who have an infection event after SLNB divided by the total number of patients implementing SLNB. The infection events include incision infection, local skin infection and injured vascular infection.
2021-12-31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

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 (Actual)

August 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 29, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20192114-C-1

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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