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Ultrasound-Based Axillary Lymph Node Reporting and Data System (ALN-RADS) for Early Invasive Breast Cancer

Ultrasound-Based Axillary Lymph Node Reporting and Data System (ALN-RADS) for Early Invasive Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113067
Enrollment
Unknown
Registered
2025-11-24
Start date
2025-05-29
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Breast cancer

Interventions

Index test:Conventional ultrasound imaging, color Doppler ultrasound

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 83 Years

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed unifocal, clinically T1-2 invasive breast cancer (2) preoperative ultrasound identifying at least one suspicious ipsilateral axillary lymph node, and clinically N1-2a; (3) Ultrasound-guided core needle biopsy performed on the most suspicious axillary lymph node; (4) Scheduled for upfront surgery with surgical pathology as reference; (5) With complete clinical, imaging, and pathological data

Exclusion criteria

Exclusion criteria: (1) Multi-focal breast cancer, clinically T stage >T2; (2) Clinically N stage >N2a; (3) False-negative or indeterminate preoperative axillary Ultrasound-guided core needle biopsy pathology; (4) Incomplete clinical or ultrasound imaging data

Design outcomes

Primary

MeasureTime frame
Area under the receiver operating characteristics curve;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predict value;Negative predictive value;Inter-reader agreement;

Countries

China

Contacts

Public ContactXiaoqing Pei

Sun Yat-sen University Cancer Center

peixq@sysucc.org.cn+86 20 8734 3212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026