Application of Deep-learning and Ultrasound Elastography in Opportunistic Screening of Breast Cancer

NCT ID: NCT03851497

Last Updated: 2021-03-26

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

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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As the most common cancer expected to occur all over the world, breast cancer still faces with the unsatisfied diagnostic accuracy in US imaging. S-detect is a sophisticated CAD system for breast US imaging based on deep learning algorithms. E-breast is a software installed in US machines which automatically reveals tumor elastographic features. This multi-center study intends to further validate the diagnostic efficiency of S-detect and E-breast in opportunistic breast cancer screening populations in China. Our hypothesis is that S-detect and E-breast can increase the diagnostic accuracy and specificity as compared to routinely US examinations by doctors.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Female over 18 years of age;
* Had breast lesions detected by ultrasound.
* No clinical symptoms such as nipple discharge, while breast lesions were not palpable.
* Received breast surgery within one week of ultrasound examination.
* Agreed to participant in this study and signed informed consent.

Exclusion Criteria

* Patients who had received a biopsy of breast lesion before the ultrasound examination.
* Patients who were pregnant or lactating.
* Patients who were undergoing neoadjuvant treatment.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Zhongguancun Hospital

UNKNOWN

Sponsor Role collaborator

Peking University Aerospace Center Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Community Health Service Center

UNKNOWN

Sponsor Role collaborator

First Hospital of Tsinghua University

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Xinxiang Central Hospital

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Yan'an Hospital of Kunming City

UNKNOWN

Sponsor Role collaborator

Xi'an Central Hospital

OTHER

Sponsor Role collaborator

Ningxia Medical University

OTHER

Sponsor Role collaborator

First Hospital of Shijiazhuang City

OTHER

Sponsor Role collaborator

Chengde Central Hospital

OTHER_GOV

Sponsor Role collaborator

Qinghai Province Cancer Hospital

UNKNOWN

Sponsor Role collaborator

Gansu Cancer Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Qingdao Central Hospital

OTHER

Sponsor Role collaborator

Jining First People's Hospital

OTHER

Sponsor Role collaborator

Linyi Tumour Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

The Second Hospital of the West Coast New Area of Qingdao

UNKNOWN

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Jiangsu Province People's Hospital

UNKNOWN

Sponsor Role collaborator

Peking University Shougang Hospital

OTHER

Sponsor Role collaborator

Gansu Jiugang Hospital

UNKNOWN

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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S-detect 2019

Identifier Type: -

Identifier Source: org_study_id

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