Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography
NCT ID: NCT03708978
Last Updated: 2021-07-27
Study Results
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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COMPLETED
5809 participants
OBSERVATIONAL
2018-04-05
2020-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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mammography group
women who receives mammography because of suspected breast lesion(s)
mammography
When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.
Interventions
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mammography
When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.
Eligibility Criteria
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Inclusion Criteria
* the results of pathological diagnosis or more than 2 years of mammography follow-up were available
* subject signs informed consent(this item was only for prospective study cases)
Exclusion Criteria
* there lacks pathological diagnosis or 2 years of mammography follow-up
* subject withdraws(this item was only for prospective study cases)
18 Years
FEMALE
No
Sponsors
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Peking University
OTHER
Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Sun Ying-Shi
Chairman of Dept.Radiology
Principal Investigators
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Ying-Shi Sun, Professor
Role: STUDY_CHAIR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chao Yang Women and Children's Health Hospital
Beijing, Beijing Municipality, China
Beijing Da Xing People's Hospital
Beijing, Beijing Municipality, China
Beijing Hang Tian Centre Hospital
Beijing, Beijing Municipality, China
Beijing Nan Jiao Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Shi Jing Shan Hospital
Beijing, Beijing Municipality, China
Beijing Shun Yi Qu Hospital
Beijing, Beijing Municipality, China
Beijing Shun Yi Woman and Children Health Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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BCA-AI
Identifier Type: -
Identifier Source: org_study_id
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