Breast ultrasound screening for older women in community clinics
Official title: A Multicenter Cluster Randomized Controlled Trial on the Necessity of Breast Cancer Ultrasound Screening in Elderly Women
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07698366 · Data updated 2026-11-12
This study tests whether offering breast ultrasound to women aged 65–80 in local communities helps find breast cancers earlier than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 80 Years |
| Sex | Women only |
| Enrollment | 80000 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 2 sites (Kunshan, Jiangsu and 1 other locations) |
| Status | Recruiting |
| Started | September 20, 2026 |
| Main results expected | September 20, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07698366 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 65–80 who live in participating communities and have not had breast cancer or recent screening within the last 2 years, and who can consent and participate.
✕Probably not a fit
Individuals with advanced comorbidities or conditions limiting follow-up or cooperation with screening may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label cluster randomized trial in Jiangsu Province, China, assigns community health stations to either provide standardized breast ultrasound screening or continue routine care. About 80,000 eligible women aged 65–80 will be enrolled and followed for up to 24 months to compare the proportion of breast cancers diagnosed at stage I or II between groups. The trial also looks at screening-related and implementation outcomes to understand practical delivery. Primary care settings and local facilities facilitate the intervention and data collection across multiple sites.
Why it matters
Potential benefit: If effective, the screening approach could lead to earlier detection of breast cancer and potentially better outcomes for older women.
How similar studies have gone: Prior research on community-based imaging screening has shown mixed results; this trial applies a large-scale, real-world design to evaluate effectiveness in an elderly population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female participants aged 65-80 years. * Local residents living in participating communities for ≥6 months. * Signed informed consent and willingness to participate. Exclusion Criteria: * History of breast cancer or previous breast cancer treatment. * Breast cancer screening within the past 2 years. * Severe comorbid conditions that may affect study participation or follow-up. * Acute breast disease or conditions requiring immediate treatment. * Unable to cooperate with screening procedures due to physical or cognitive limitations.
Where it's running
-
Kunshan First People's Hospital
Kunshan, Jiangsu, China Recruiting -
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Not yet recruiting
Study contacts
- Study coordinator: Ge Ma, doctor
- Email: ntmage@sina.com
- Phone: +8618262632870
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.