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

NCT07698366 | Recruiting DMC

• 4 other identifiers: JS-BC-Elder-Screen-20262024ZD05240002024ZD05240042025ZD0545404
• Study Type: interventional
• Target: 80,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Neoplasms; Early Detection of Cancer

Outcome Measures

Primary Outcomes (1)

• Absolute difference in early-stage breast cancer diagnosis rate

  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 Outcomes (3)

• Overall breast cancer detection rate

  24 months

• Late-stage breast cancer diagnosis rate

  Up to 24 months after enrollment

• Breast biopsy rate

  Up to 24 months after enrollment

Study Arms (2)

Ultrasound Active Screening Group

EXPERIMENTAL

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

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 DIAGNOSTIC_TEST

One standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate.

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 (2)

Kunshan First People's Hospital

Kunshan, Jiangsu, China

RECRUITING

The Fourth Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

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: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): September 20, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)