Breast lump
Conditions
Interventions
Gold Standard:Paraffin pathological examination
Index test:Real-time diagnostic results of ES
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. patients with clinically suspected breast cancer who consent to undergo planned needle biopsy; 3. subjects voluntarily sign an informed consent form or are exempted from signing following review and approval by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Patients refusing puncture or with contraindications to puncture; 2. patients with a history of confirmed malignancy; 3. those with psychiatric disorders or cognitive impairment; 4. those with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall agreement rate, sensitivity, and specificity between real-time ES diagnosis and paraffin pathological diagnosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in ES interpretation accuracy across different BI-RADS categories;Difference in accuracy between ES interpretation and frozen rapid pathological examination;Difference in time between ES interpretation and frozen rapid pathological testing; | — |
Countries
China
Contacts
Public ContactMa Xiaopeng
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed