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

Qualifiers

Female participants aged 65-80 years.

Local residents living in participating communities for ≥6 months.

Signed informed consent and willingness to participate.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Standardized Breast Ultrasound Screening

Treatment groups

82,440 Participants
are divided into 2 treatment groups