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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04156841
Enrollment
21000
Registered
2019-11-08
Start date
2019-08-01
Completion date
2021-12-31
Last updated
2019-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Sentinel Lymph Node

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.

Interventions

DIAGNOSTIC_TESTmapping 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.

PROCEDUREneoadjuvant chemotherapy

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

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the performance rate of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China2020-12-31the performance rate of SLNB refers to the number of patients implementing SLNB divided by the total number of breast cancer patients
the positive rate of SLNs in patients with early stage breast cancer in China2020-12-31SLNs positive rate is the number of positive SLN patients divided by the number of patients implementing SLNB
the number of resected SLNs in patients with early stage breast cancer in China2020-12-31the average number of resected SLNB will be calculated

Secondary

MeasureTime frameDescription
incidence of infection events after SLNB in patients with early stage breast cancer in China2021-12-31incidence 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.

Countries

China

Contacts

Primary ContactJuliang Zhang
ycj617655094@163.com029-84775271

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026