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)

Seoul National University Hospital

Seoul, South Korea

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NCT05460975


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