Clinical trial · Observational
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
NCT05460975CI-TRIAL-00077728recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Screening | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incident breast cancer within 3 months to 7 years after the assessment of sonographic GTC
- timeFrame
- from 3 months to 7 years after the GTC assessment
- description
- The 5-year cumulative incidence of breast cancer and hazard ratio by level of sonographic GTC using standardized risk
Secondary outcomes (4)
- measure
- Correlation of sonographic GTC with risk according to tumor type
- timeFrame
- from 3 months to 7 years after the GTC assessment
- description
- Correlation of sonographic GTC with risk according to tumor type (DCIS vs. invasive cancer)
- measure
- Correlation of sonographic GTC with breast cancer according to the breast US device
- timeFrame
- from 3 months to 7 years after the GTC assessment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLee SH, Moon WK. Glandular Tissue Component on Breast Ultrasound in Dense Breasts: A New Imaging Biomarker for Breast Cancer Risk. Korean J Radiol. 2022 Jun;23(6):574-580. doi: 10.3348/kjr.2022.0099. No abstract available. PMID 35617993
- BACKGROUNDLee SH, Ryu HS, Jang MJ, Yi A, Ha SM, Kim SY, Chang JM, Cho N, Moon WK. Glandular Tissue Component and Breast Cancer Risk in Mammographically Dense Breasts at Screening Breast US. Radiology. 2021 Oct;301(1):57-65. doi: 10.1148/radiol.2021210367. Epub 2021 Jul 20. PMID 34282967
- BACKGROUNDAcciavatti RJ, Lee SH, Reig B, Moy L, Conant EF, Kontos D, Moon WK. Beyond Breast Density: Risk Measures for Breast Cancer in Multiple Imaging Modalities. Radiology. 2023 Mar;306(3):e222575. doi: 10.1148/radiol.222575. Epub 2023 Feb 7. PMID 36749212