Breast Ultrasound Screening in Elderly Women: A Multicenter Cluster Randomized Trial

September 23, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University

A Multicenter Cluster Randomized Controlled Trial on the Necessity of Breast Cancer Ultrasound Screening in Elderly Women

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Kunshan, Jiangsu, China
        • Recruiting
        • Kunshan First People's Hospital
        • Contact:
          • Qin Zhou, doctor
          • Phone Number: +86-18626179180
          • Email: 4527472@qq.com
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • The Fourth Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound Active Screening Group

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

One standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate.
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
Time Frame: 24 months after enrollment

The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II.
24 months after enrollment

Secondary Outcome Measures

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

The proportion of participants diagnosed with breast cancer in each group during follow-up.
24 months
Late-stage breast cancer diagnosis rate
Time Frame: Up to 24 months after enrollment

The proportion of participants diagnosed with stage III or IV breast cancer in each group.
Up to 24 months after enrollment
Breast biopsy rate
Time Frame: Up to 24 months after enrollment

The proportion of participants undergoing a breast biopsy in each group during follow-up.
Up to 24 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2026

Primary Completion (Estimated)

September 20, 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)

September 28, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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