An interventional study of Standardized Breast Ultrasound Screening in Breast Neoplasms and Early Detection of Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 2 sites in China. Open to female participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Screening
This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Approximately 80,000 women in Jiangsu Province, China, will be enrolled and followed for breast cancer outcomes.
This is a multicenter, open-label, cluster randomized controlled trial in Jiangsu Province, China. Approximately 80,000 women aged 65 to 80 years will be enrolled. Participating community health service stations will be assigned to either active breast ultrasound screening or routine health management. Women in the screening group will receive a standardized breast ultrasound examination, while those in the control group will receive no additional study-specific breast screening. The primary outcome is the difference between groups in the proportion of diagnosed breast cancers that are stage I or II during 24 months of follow-up. The study will also assess other screening-related and implementation outcomes.
Exclusion Criteria:
Participants assigned to this group through their community health service station receive one standardized breast ultrasound examination performed by a qualified physician. Abnormal findings are managed according to routine clinical practice.
Diagnostic Test: Standardized Breast Ultrasound Screening
Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening.
One standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate.
Absolute difference in early-stage breast cancer diagnosis rate
The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II.
Time frame: 24 months after enrollment
Overall breast cancer detection rate
The proportion of participants diagnosed with breast cancer in each group during follow-up.
Time frame: 24 months
Late-stage breast cancer diagnosis rate
The proportion of participants diagnosed with stage III or IV breast cancer in each group.
Time frame: Up to 24 months after enrollment
Breast biopsy rate
The proportion of participants undergoing a breast biopsy in each group during follow-up.
Time frame: Up to 24 months after enrollment
Plan to share: No — Individual participant data will not be shared because there is currently no approved data sharing policy for this multicenter study. De-identified participant data will be managed in accordance with institutional regulations and applicable ethical and legal requirements.
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The First Affiliated Hospital with Nanjing Medical University