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

NCT07698366 | Not Yet Recruiting DMC

• 4 other identifiers: JS-BC-Elder-Screen-20262024ZD05240002024ZD05240042025ZD0545404
• Study Type: interventional
• Target: 82,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Early Detection of Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall breast cancer detection rate

  24 months

Study Arms (2)

Ultrasound Active Screening Group

EXPERIMENTAL

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

Routine Health Management Group

NO INTERVENTION

Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening.

Interventions

Standardized Breast Ultrasound Screening PROCEDURE

Retrospective AI image analysis for research use only, not involved in clinical decision-making.

Ultrasound Active Screening Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Female participants aged 65-80 years.
• Local residents living in participating communities for ≥6 months.
• Signed informed consent and willingness to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Kunshan First People's Hospital

Kunshan, Jiangsu, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ge Ma, doctor

CONTACT

+8618262632870; ntmage@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 10, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)