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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 to the current local guidelines in each participating area) in detecting late-stage breast cancers.
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 intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI assisted B-ultrasound breast cancer screening | Experimental | Participants aged 35-70 years will be screened for breast cancer with AI assisted B-ultrasound |
|
| routine screening | Active Comparator | Participants aged 35-70 years will be screened for breast cancer with routine B-ultrasound by experienced primary care physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted breast ultrasound | Device | AI-assisted breast ultrasound in community-based breast cancer screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of early breast cancer in each arm | Early cancers should meet any of the following criteria at the time of diagnosis: less than 20 milimeters in diameter, no metastatic lymph nodes in the axilla, no distant metastasis, non-invasive cancers, stage 0, stage I, and stage IIa IIb (T2N1M0) breast cancer according to American Joint Committee on Cancer (AJCC) 8th staging. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods | A true-positive screening result (sensitivity) was a positive result in a participant who was diagnosed with breast cancer by further diagnostic work-up. A false-positive screening result was a positive result in the absence of breast cancer. A true-negative screening result (specificity) was a negative result in the absence of breast cancer and a false-negative test result was a negative result followed by diagnosis of interval cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Zheng | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Infant Healthy Centre of Hongkou District, Shanghai | Shanghai | Shanghai Municipality | 200086 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057952 | Derived | Shen J, Liu Y, Liu A, Gu X, Zhou J, Jiang P, Mo M, Zhang L, Yang C, Zhou C, Wang Z, Xie Z, Yao W, Zhou S, Zheng Y, Chang C. Artificial intelligence-assisted ultrasound screening for breast cancer in China: a prospective, clustered, controlled, population-based study. Breast Cancer Res. 2025 Oct 7;27(1):173. doi: 10.1186/s13058-025-02128-0. |
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We will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
The data shared will be limit to that required for independent mandated verification of the published results. And the data will only be transferred after signing of a data access agreement.
The study chairman will consider access to study data upon written detailed request sent to her, from 6 months until 5 years after publication of summary data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | Jul 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Routine breast ultrasound | Device | Routine breast ultrasound conducted by primary care physicians |
|
| 4 years |
| Fudan University Shanghai Cancer Center |
| Shanghai |
| China |
| Shanghai Pudong New Area Healthcare Hospital For Women & Children | Shanghai | China |
| D017437 |
| Skin and Connective Tissue Diseases |