RecruitingNCT05460975
Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)
Association of Sonographic Glandular Tissue Component With Breast Cancer Risk Among Women With Dense Breasts: A Prospective, Multinational Validation Study
Sponsor
Seoul National University Hospital
Enrollment
16,164 participants
Start Date
Nov 1, 2022
Study Type
OBSERVATIONAL
Conditions
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: FEMALEMin Age: 40 YearsMax Age: 69 Years
Inclusion Criteria4
- be ≥ 40 and \<70 years old at time of US
- No history of previous breast cancer including DCIS
- 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)
- undergoing screening breast US using either automated or handheld device
Exclusion Criteria6
- history of bilateral prophylactic mastectomy
- history of bilateral foreign body injection
- history of bilateral breast implants
- history of bilateral breast reduction surgery or surgical excision
- currently pregnant or breast feeding in the preceding 6 months
- Known distant metastasis from other primary cancer
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05460975
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