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Search / Trial NCT05460975

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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jul 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Dense Breast Risk Factors Ultrasonography

ClinConnect Summary

The International GTC Study is a clinical trial that aims to understand how certain features seen in breast ultrasound (specifically, glandular tissue) may be linked to the risk of developing breast cancer in women with dense breast tissue. Dense breasts can make it harder to spot cancer on mammograms, so this study hopes to find out if the ultrasound characteristics can help identify women who might be at a higher risk for breast cancer.

To participate in this study, women need to be between 40 and 70 years old, have dense breasts as shown in a recent mammogram, and have no history of breast cancer. Participants will undergo a screening breast ultrasound, which can be done using specialized devices. It’s important to note that women who have had certain surgeries, are currently pregnant, or have other specific medical histories may not be eligible. If you join the study, you'll be contributing to important research that could improve breast cancer screening in the future.

Gender

FEMALE

Eligibility criteria

  • 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

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Woo Kyung Moon, MD, PhD

Principal Investigator

Seoul National University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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