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

May 31, 2024 updated by: Woo Kyung Moon, Seoul National University Hospital

Association of Sonographic Glandular Tissue Component With Breast Cancer Risk Among Women With Dense Breasts: A Prospective, Multinational Validation Study

An international multicenter study to prospectively validate the association between sonographic GTC and subsequent breast cancer risk in women with dense breasts.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Women with similarly dense breasts on mammography may have different subsequent risks of developing breast cancer due to varying degrees of lobular involution. Breast ultrasound (US) can assess the relative amount of glandular tissue component (GTC) to the fibrous stroma in dense breast parenchyma and can reflect the amount of terminal duct lobular units (TDLU) as seen in histology. In women with dense breasts on mammography, an association between high levels of sonographic GTC, defined as the percent of glandular tissue within fibroglandular tissue, and an increased risk of breast cancer was demonstrated in a retrospective single-center study of 8483 Korean women. The purpose of this international multicenter study is to prospectively validate whether sonographic GTC is associated with subsequent breast cancer risk and whether it can provide additional information beyond established risk factors. In this study, investigators will enroll 16164 women with dense breasts (BI-RADS density categories C and D on mammography) undergoing screening breast US using either an automated or handheld device. GTC will be assessed qualitatively as minimal, mild, moderate, or marked at the time of US interpretation and will be dichotomized into low (minimal or mild) versus high (moderate or marked). The primary outcome is a pathologic diagnosis of breast cancer, including invasive cancer and ductal carcinoma in situ (DCIS). Women are observed from 3 months after date of GTC assessment to breast cancer diagnosis or censoring as a result of death or end date of complete cancer capture. Covariate information will be obtained from self-report at the time of breast US examination and includes age, race/ethnicity, menopausal status, first-degree family history of breast cancer, breast density, history of benign breast biopsy, BMI, age at first live birth, and hormone replacement therapy (HRT) usage. The 5-year cumulative incidence of breast cancer by level of sonographic GTC will be compared based on marginal standardization with the predicted risk summed to a weighted risk according to the observed covariate distribution in the study population. The association of sonographic GTC with breast cancer risk will be estimated by using the Fine-Gray subdistribution hazards model to account for the competing risk of death. In addition, investigators will compare the discriminatory accuracy of the breast cancer surveillance consortium (BCSC) 5-year risk score and the BCSC model integrated with sonographic GTC.

Study Type

Observational

Enrollment (Estimated)

16164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Woo Kyung Moon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

16164 women

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident breast cancer within 3 months to 7 years after the assessment of sonographic GTC
Time Frame: from 3 months to 7 years after the GTC assessment
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of sonographic GTC with risk according to tumor type
Time Frame: from 3 months to 7 years after the GTC assessment
Correlation of sonographic GTC with risk according to tumor type (DCIS vs. invasive cancer)
from 3 months to 7 years after the GTC assessment
Correlation of sonographic GTC with breast cancer according to the breast US device
Time Frame: from 3 months to 7 years after the GTC assessment
Correlation of sonographic GTC with breast cancer according to the breast US device (hand-held vs. automated)
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)
Time Frame: 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) for the BCSC model (5-year risk score) and BCSC model integrated with sonographic GTC
from 3 months to 7 years after the GTC assessment
Breast US diagnostic performance according to sonographic GTC
Time Frame: from the examination till 1 year after the GTC assessment
Sensitivity, specificity, positive predictive value
from the examination till 1 year after the GTC assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Woo Kyung Moon, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

December 30, 2031

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 15, 2022

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast Cancer Risk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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