Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized Breast Ultrasound Screening.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Early Detection of Cancer. Basic parameters: 65 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening
Overview
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
- Procedure Standardized Breast Ultrasound Screening
Retrospective AI image analysis for research use only, not involved in clinical decision-making.
Primary outcome measures
- Absolute difference in early-stage breast cancer diagnosis rate [Time frame: 24 months after enrollment]
Secondary outcome measures (1)
- Overall breast cancer detection rate [Time frame: 24 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
China · 1 center
- Kunshan First People's Hospital — Kunshan
Identifiers
NCT: NCT07698366 · JS-BC-Elder-Screen-2026 · 2024ZD0524000 · 2024ZD0524004 · 2025ZD0545404