Ultrasound-Guided Core Needle Biopsy to Assess Sensitivity and Specificity of Axillary Lymph Node Metastasis in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lymphatic Metastasis, Breast Neoplasms. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sensitivity and Specificity of Ultrasound-Guided Core Needle Biopsy in Evaluating Axillary Lymph Node Metastasis in Breast Cancer
Overview
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.
Primary outcome measures
- Maximum cortical thickness of the lymph node (mm) [Time frame: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.]
Secondary outcome measures (5)
- Age [Time frame: Baseline]
- Menstrual Status [Time frame: At initial diagnosis of primary breast cancer]
- Lymph node axial ratio [Time frame: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.]
- Lymph node margin regularity [Time frame: Measurements should be performed prior to treatment initiation, with a time interval not exceeding 4 weeks between the measurement and pathological examination.]
- Lymph node hilum type [Time frame: Within 4 weeks before pathological examination and prior to treatment initiation]
Eligibility criteria
Inclusion criteria
- Age ≥18 years and <70 years;
- Histologically confirmed primary breast cancer;
- Underwent ultrasound examination to assess axillary lymph node metastasis status.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07573657 · 25K072-001