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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156841
• Other study ID #: KY20192114-C-1
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2019
• Source: Xijing Hospital
• Contact: Juliang Zhang
• Phone: 029-84775271
• Email: ycj617655094[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

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.

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

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	incidence of infection events after SLNB in patients with early stage breast cancer in China	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