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

NCT ID: NCT04156841

Last Updated: 2019-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

21000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Sentinel Lymph Node

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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performed SLNB using a single mapping agent

mapping agent

Intervention Type DIAGNOSTIC_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 radiotracer

mapping agent

Intervention Type DIAGNOSTIC_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.

underwent SLN surgery receiving neoadjuvant chemotherapy

neoadjuvant chemotherapy

Intervention Type PROCEDURE

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

underwent SLN surgery not receiving neoadjuvant chemotherapy

neoadjuvant chemotherapy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

neoadjuvant chemotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juliang Zhang

Role: CONTACT

029-84775271 ext. 13572900544

Facility Contacts

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Rui Ling

Role: primary

029-84775271

Other Identifiers

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KY20192114-C-1

Identifier Type: -

Identifier Source: org_study_id

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