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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080623
• Other study ID #: D161100000816006
• Status: Completed
• Start date: September 8, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1981
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Diagnoses Disease

Locations

Country	Name	City	State
China	Haidian women and children's hospital of beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Shunyi women and children's hospital of Beijing Children's Hospital	Beijing
China	Fourth Hospital of Heibei Medical Hospital	Shijiazhuang

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)