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

Completed

• Conditions: Breast Cancer Female; Diagnoses Disease

• Registration Number: NCT03080623
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2018-09-08
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1981

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
breast biopsy proved malignant or benign lesion	between breast ultrasound and biopsy(one week)	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
two breast ultrasound identified benign lesion	between first detection of breast lesion and the second ultrasound(six month)	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

Trial Locations

Locations (4)

Fourth Hospital of Heibei Medical Hospital; 🇨🇳 Shijiazhuang, China

Shunyi women and children's hospital of Beijing Children's Hospital; 🇨🇳 Beijing, China

Haidian women and children's hospital of beijing; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China