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

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.

NCT Number	NCT07698366
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Breast Neoplasms, Early Detection of Cancer
Enrollment	82,440 participants
Start Date	2026-07-10
Primary Completion	2029-07-10 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-14