Association of Sonographic Glandular Tissue Component With Breast Cancer Risk Among Women With Dense Breasts: A Prospective, Multinational Validation Study
Sponsor study identifier
observational
16,164
1 country
1
Study Start
November 1, 2022
Actual (reported)Primary Completion
March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2022
Actual (reported)July 15, 2022
Actual (reported)November 1, 2022
Actual (reported)March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incident breast cancer within 3 months to 7 years after the assessment of sonographic GTC
The 5-year cumulative incidence of breast cancer and hazard ratio by level of sonographic GTC using standardized risk
from 3 months to 7 years after the GTC assessment
Correlation of sonographic GTC with risk according to tumor type
from 3 months to 7 years after the GTC assessment
Correlation of sonographic GTC with breast cancer according to the breast US device
from 3 months to 7 years after the GTC assessment
The expected-to-observed (E/O) number of cancer diagnoses and concordance index (discriminatory accuracy)
from 3 months to 7 years after the GTC assessment
Breast US diagnostic performance according to sonographic GTC
from the examination till 1 year after the GTC assessment
16164 women
Seoul National University Hospital
Seoul, South Korea
Lee 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.
Lee 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.
Woo Kyung Moon, MD, PhD
Seoul National University Hospital
First Submitted
July 12, 2022
First Posted
July 15, 2022
Study Start
November 1, 2022
Actual (reported)Primary Completion
March 30, 2026
Estimated (date passed)Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy
Contact the study team to confirm eligibility.
Acciavatti 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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 4, 2024
Record last verified: 2024-05
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