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Clinical Trials in South Korea / NCT05460975
Recruiting Observational

Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)

NCT05460975 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Observational
Started
2022-11-01
Last updated
2024-06-04

Condition(s) studied

Breast CancerScreening

Study summary

An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
69 Years
Healthy volunteers
No
Inclusion Criteria 1. be ≥ 40 and \<70 years old at time of US 2. No history of previous breast cancer including DCIS 3. have dense breasts (BI-RADS category C and D on mammography performed within 12 months of breast US) and negative/benign BI-RADS assessment categories on mammography (BI-RADS 1, 2) 4. undergoing screening breast US using either automated or handheld device Exclusion Criteria 1. history of bilateral prophylactic mastectomy 2. history of bilateral foreign body injection 3. history of bilateral breast implants 4. history of bilateral breast reduction surgery or surgical excision 5. currently pregnant or breast feeding in the preceding 6 months 6. Known distant metastasis from other primary cancer

Primary outcome measure(s)

  • Incident breast cancer within 3 months to 7 years after the assessment of sonographic GTC — from 3 months to 7 years after the GTC assessment
    The 5-year cumulative incidence of breast cancer and hazard ratio by level of sonographic GTC using standardized risk

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05460975 on ClinicalTrials.gov ↗ ← All trials in South Korea