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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age65-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

History of breast cancer Breast screening within past 2 years Severe comorbid conditions affecting survival Acute breast infection Cognitive impairment affecting participation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Breast Ultrasound Screening

    Procedure/Surgery

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

Treatment groups

82,440 Participants
are divided into 2 treatment groups
Group A: Ultrasound Active Screening GroupExperimental treatment 1 intervention
Group B: Routine Health Management GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
24 months after enrollment

Secondary outcomes

1

Overall breast cancer detection rate

Overall breast cancer detection rate

Time frame
24 months

Other outcomes

Sponsors and contacts

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