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NCT07698366
NA

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening

Key Details

Gender

FEMALE

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

82440

Start Date

2026-07-10

Completion Date

2029-12-31

Last Updated

2026-07-14

Healthy Volunteers

Yes

Interventions

PROCEDURE

Standardized Breast Ultrasound Screening

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

Locations (1)

Kunshan First People's Hospital

Kunshan, Jiangsu, China