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

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 Overview

• Status: Completed
• Conditions: Diagnoses Disease; Breast Cancer Female

• Study Type: Observational
• Enrollment (Actual): 1981

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Haidian women and children's hospital of beijing
  • Beijing, China
    • Shunyi women and children's hospital of Beijing Children's Hospital
  • Shijiazhuang, China
    • Fourth Hospital of Heibei Medical Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

females with breast lesion who need to receive breast ultrasound to make differential diagnosis of benign and malignant lesion

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Chair: Tao Ouyang, Peking University Cancer Hospital & Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: D161100000816006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No