Breast Cancer
Conditions
Brief summary
To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.
Interventions
DIAGNOSTIC_TESTimaging
perform US and mammography examination
Sponsors
The First Affiliated Hospital of the Fourth Military Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Inclusion criteria
1. Women aged 18 years and over with full capacity for civil conduct; 2. Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy; 3. Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test; 4. The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements; 5. It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).
Exclusion criteria
1. Women are participating in another clinical trial of drug or medical device; 2. Women with neuropsychiatric disorders; 3. Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial; 4. Other subjects not suitable for X-ray examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitive | 3 days | Proportion of corrected-detected malignant lesions by the US or MG |
| Specificity | 3 days | Proportion of corrected-detected benign lesions by the US or MG |
| Area under curve | 3 days | Area under receiver operating characteristic (ROC) curve in percentage (%) |
| Disease-free survival (DFS) | 3 years | The time that the patient is free of the signs and symptoms of a disease after treatment. |
Countries
China
Contacts
Primary ContactHongping Song, MD
Outcome results
None listed