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

Peking University1,981 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,981

Conditions

Breast Cancer Female Diagnoses Disease

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Haidian women and children's hospital of beijing

Beijing, China

Shunyi women and children's hospital of Beijing Children's Hospital

Beijing, China

Fourth Hospital of Heibei Medical Hospital

Shijiazhuang, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: between first detection of breast lesion and the second ultrasound(six month)

Data from ClinicalTrials.gov

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