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

NCT ID: NCT03080623

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1981 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-08

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Female Diagnoses Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

Chairman of Breast Center of Beijing Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tao Ouyang

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Haidian women and children's hospital of beijing

Beijing, , China

Site Status

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

Beijing, , China

Site Status

Fourth Hospital of Heibei Medical Hospital

Shijiazhuang, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33889025 (View on PubMed)

Other Identifiers

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D161100000816006

Identifier Type: -

Identifier Source: org_study_id