Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion

Peking University

Status: Completed

Conditions: Breast Cancer Female; Diagnoses Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03080623

D161100000816006

Details and patient eligibility

About

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.

Enrollment: 1,981 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• with single breast lesion(maximum diameter>0.8 cm)
• agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
• sign the informed consent

Exclusion criteria

• lost to follow-up
• failed to take the second breast ultrasound six month after the first breast ultrasound

Trial design

1,981 participants in 1 patient group

Suspicious breast lesions

Description:

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