About this trial
This study plans to find the most suitable lymph node cortex thickness and abnormal lymph node features to define suspicious lymph nodes. Then, ultrasound-guided core needle biopsy of axillary lymph nodes will be done, aiming to provide some guidance for the biopsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and <70 years;
Histologically confirmed primary breast cancer;
Underwent ultrasound examination to assess axillary lymph node metastasis status.
Disqualifiers
Presence of other malignancies (e.g., lymphoma, lung cancer, thyroid cancer, etc., with axillary metastasis);
Pregnant or lactating women;
Previous receipt of neoadjuvant radiotherapy or chemotherapy;
Lymph node metastasis status not confirmed by pathology, or time interval between ultrasound examination and pathological confirmation exceeding 6 weeks.
Trial population
Consecutive patients newly diagnosed with primary breast cancer and assessed for axillary lymph node metastasis by ultrasound, prospectively enrolled from November 2025 to November 2026 across multiple hospitals.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Maximum cortical thickness of the lymph node (mm)
The maximum thickness of the lymph node's cortical layer. Measured via conventional ultrasound examination of the lymph node's long-axis cross-section, perpendicular to the capsule surface, determining the maximum distance from the capsule to the corticomedullary junction.
Secondary outcomes
Age
Age of participants at the time of initial diagnosis of primary breast cancer, reported in years.
Menstrual Status
Menstrual status at initial diagnosis of primary breast cancer, assessed by medical record review and categorized as premenopausal, perimenopausal, postmenopausal, or unknown.
Lymph node axial ratio
The ratio of the maximum longitudinal diameter to the maximum transverse diameter of the lymph node. The maximum longitudinal diameter and maximum transverse diameter of the lymph node are measured separately, and the axial ratio is obtained by dividing the measured longitudinal diameter value by the transverse diameter value.
Lymph node margin regularity
Categorized as either regular or irregular.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Hospital of Jilin University
Lead sponsor
Siping Central People's Hospital
Collaborator
Baicheng Central Hospital
Collaborator
Jilin Central General Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: