Status:
COMPLETED
Artificial Intelligence Assisted Breast Ultrasound in Breast Cancer Screening
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Screening
Eligibility:
FEMALE
35-70 years
Phase:
NA
Brief Summary
AIBU is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according...
Detailed Description
we enrolled asymptomatic women Women From January 2021 to December 2022, and then followed up for the next 1 year. The main study endpoint will be measured at the end of the one year after interventio...
Eligibility Criteria
Inclusion
- Women aged 35-70 who participated in breast cancer screening (Shanghai Rural Women "Women two cancer screening project", national major public health service project "Rural women breast cancer screening Project" and "Gynecological diseases and breast diseases screening project for retired and living difficult women") in Shanghai district
Exclusion
- 1\. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS); 2. Personal history of any types of malignant neoplasms; 3. Known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases; 4. Known condition or suspicion of serious comorbidities and average life expectancy less than 5 years; 5. History of lateral or bilateral mastectomy; 6. Disagree to participate in the study and follow-up interviews.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
21790 Patients enrolled
Trial Details
Trial ID
NCT06521788
Start Date
September 1 2020
End Date
December 31 2023
Last Update
July 26 2024
Active Locations (3)
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1
Maternal and Infant Healthy Centre of Hongkou District, Shanghai
Shanghai, Shanghai Municipality, China, 200086
2
Fudan University Shanghai Cancer Center
Shanghai, China
3
Shanghai Pudong New Area Healthcare Hospital For Women & Children
Shanghai, China