Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)
Recruiting · NCT05460975 · Observational (researchers observe without assigning treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
Who can take part
Age range
40 Years to 69 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, South Korea