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This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspicious breast lesions | women with Suspicious breast lesions, who need to receive breast ultrasound will be collected in this cohort. According to the diagnosis of breast ultrasound，patients will be assigned to breast biopsy or follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| breast biopsy proved malignant or benign lesion | for patients regarded as malignant by the breast ultrasound, breast biopsy results are used as reference test, which determines the breast lesion is malignant or benign | between breast ultrasound and biopsy(one week) |
| two breast ultrasound identified benign lesion | for patients regarded as benign by the breast ultrasound, they will receive a second breast ultrasound after six month(this is regular examination for patients with first detected breast lesion). If the second ultrasound indicates benign, the lesion will be regarded as benign | between first detection of breast lesion and the second ultrasound(six month) |
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Inclusion Criteria:
Exclusion Criteria:
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females with breast lesion who need to receive breast ultrasound to make differential diagnosis of benign and malignant lesion
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| Name | Affiliation | Role |
|---|---|---|
| Tao Ouyang | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Haidian women and children's hospital of beijing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33889025 | Derived | Huo L, Tan Y, Wang S, Geng C, Li Y, Ma X, Wang B, He Y, Yao C, Ouyang T. Machine Learning Models to Improve the Differentiation Between Benign and Malignant Breast Lesions on Ultrasound: A Multicenter External Validation Study. Cancer Manag Res. 2021 Apr 16;13:3367-3379. doi: 10.2147/CMAR.S297794. eCollection 2021. |
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Breast biopsy pathology
| Beijing |
| China |
| Shunyi women and children's hospital of Beijing Children's Hospital | Beijing | China |
| Fourth Hospital of Heibei Medical Hospital | Shijiazhuang | China |