Breast Neoplasms, Early Detection of Cancer
Conditions
Brief summary
This multicenter study aims to evaluate whether active breast ultrasound screening can improve the early diagnosis rate of breast cancer in women aged 65 to 80 years, compared with routine elderly health management. The study uses a mixed cluster-individual randomized design based on community implementation capacity. A subgroup of pilot communities will simultaneously collect ultrasound AI data for research performance analysis only, without affecting clinical diagnosis.
Detailed description
This is a multicenter, open-label, mixed cluster-individual randomized controlled trial conducted in Jiangsu Province, China. A total of 82,440 elderly women aged 65-80 years will be enrolled and assigned to either the ultrasound active screening group or the routine health management group. Communities with limited screening capacity will be randomized as clusters, while communities with individual screening conditions will randomize participants individually. The primary endpoint is the absolute difference in the diagnosis rate of early-stage breast cancer between the two groups within 2 years of follow-up. In pilot communities of the screening group, an ultrasound AI system will be deployed synchronously to verify its diagnostic performance, homogenization effect on primary care physicians, and health economic value. All clinical diagnosis and endpoint adjudication are based on manual ultrasound reports; AI results are only used for retrospective scientific research and do not interfere with clinical decision-making.
Interventions
PROCEDUREStandardized Breast Ultrasound Screening
Retrospective AI image analysis for research use only, not involved in clinical decision-making.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute difference in early-stage breast cancer diagnosis rate | 24 months after enrollment | Proportion of pathologically confirmed breast cancer cases at stage I or stage II, compared between the ultrasound screening group and the routine management group within 2-year follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall breast cancer detection rate | 24 months | Overall breast cancer detection rate |
Countries
China
Contacts
CONTACTGe Ma, doctor
Outcome results
None listed