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NCT07698366
Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT
Conditions: Breast Neoplasms, Early Detection of Cancer
Sex: Female
Ages: 65 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 82440
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Location: Kunshan First People's Hospital Kunshan Jiangsu
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.
Eligibility Criteria
Inclusion Criteria:
* Female participants aged 65-80 years.
* Local residents living in participating communities for ≥6 months.
* Signed informed consent and willingness to participate.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07698366). StuddyBuddy aggregates publicly available trial information.
