Recruiting
Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
ClinicalTrials.gov IDNCT05460975
PhaseNot Applicable
Enrollment16164
SponsorSeoul National University Hospital
Age40 Years
SexFEMALE
Conditions studied
Breast Cancer, Screening
About this study
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
Primary outcomes
- 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)
Eligibility information
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
Study locations
- Seoul National University Hospital, Seoul, South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.