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Multi-center study on the effectiveness of artificial intelligence in ultrasound screening for breast cancer

Multi-center study on the effectiveness of artificial intelligence in ultrasound screening for breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099551
Enrollment
Unknown
Registered
2025-03-25
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer is one of the major malignant tumors that endanger women's health, and it has become the most common cancer in the world. The clinical manifestations of early breast cancer are subtle. As the disease progresses, a hard, painless mass with poor mobility can often be felt, which may be accompanied by skin changes such as orange peel-like changes, and the nipple may be involved and retr

Interventions

Gold Standard:Obtain final pathological results or no changes in imaging re-examination within one year
Index test:Artificial Intelligence Breast Auxiliary Diagnosis System (Yizhun DBU)

Sponsors

Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1.10000 women aged 40-69 (based on the principle of maximizing benefits under limited resources, the relatively high incidence age group of breast cancer, such as people aged 45-60, can be enriched into the group); 2.Ability to understand research procedures; 3.Voluntarily sign a written informed consent form; 4.There is no typical breast cancer sign visible to the naked eye;

Exclusion criteria

Exclusion criteria: 1. Pregnant, breastfeeding, or planning to conceive; 2. History of Surgery and Radiotherapy for Breast Malignant Tumors; 3.Breast implants; 4. Patients who undergo percutaneous puncture within one year; 5. Cases that have not completed one-year follow-up; 6. Suspected malignant cases without clear pathological results;

Design outcomes

Secondary

MeasureTime frame
sensitivity;specificity;Positive predictive value;accuracy;Diagnostic efficiency;

Primary

MeasureTime frame
recall rate;detection rate;

Countries

China

Contacts

Public ContactLingyun Bao

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

hzs1bly@zju.edu.cn+86 571 56007130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026