Breast Cancer Risk From Sonographic Glandular Tissue Component (or International GTC Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-69
SponsorSeoul National University Hospital
About this trial
An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
16164 women
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
from 3 months to 7 years after the GTC assessmentSecondary outcomes
1
Correlation of sonographic GTC with risk according to tumor type
Correlation of sonographic GTC with risk according to tumor type (DCIS vs. invasive cancer)
Time frame
from 3 months to 7 years after the GTC assessment2
Correlation of sonographic GTC with breast cancer according to the breast US device
Correlation of sonographic GTC with breast cancer according to the breast US device (hand-held vs. automated)
Time frame
from 3 months to 7 years after the GTC assessment3
The expected-to-observed (E/O) number of cancer diagnoses and concordance index (discriminatory accuracy)
The expected-to-observed (E/O) number of cancer diagnoses and concordance index (discriminatory accuracy) for the BCSC model (5-year risk score) and BCSC model integrated with sonographic GTC
Time frame
from 3 months to 7 years after the GTC assessment4
Breast US diagnostic performance according to sonographic GTC
Sensitivity, specificity, positive predictive value
Time frame
from the examination till 1 year after the GTC assessmentSponsors and contacts
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Source ClinicalTrials.gov