Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT

A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms; Early Detection of Cancer
• Intervention / Treatment: Procedure: Standardized Breast Ultrasound Screening

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.

• Study Type: Interventional
• Enrollment (Estimated): 82440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ge Ma, doctor; Phone Number: +8618262632870; Email: ntmage@sina.com

Study Locations

• China
  • Jiangsu
    • Kunshan, Jiangsu, China
      • Kunshan First People's Hospital
      • Contact: Qin Zhou, doctor; Phone Number: +86-18626179180; Email: 4527472@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound Active Screening Group; Participants receive one standardized breast ultrasound examination performed by certified primary care physicians during annual health check-ups. In selected pilot communities, an ultrasound AI system is deployed synchronously for image data collection and retrospective scientific analysis only; AI results do not affect clinical diagnosis or report issuance.	Procedure: Standardized Breast Ultrasound Screening; Retrospective AI image analysis for research use only, not involved in clinical decision-making.
No Intervention: Routine Health Management Group; Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute difference in early-stage breast cancer diagnosis rate	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.	24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall breast cancer detection rate	Overall breast cancer detection rate	24 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): July 10, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: JS-BC-Elder-Screen-2026; 2024ZD0524000 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project); 2024ZD0524004 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project); 2025ZD0545404 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No