NCT05460975

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,164

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Nov 2022Dec 2031

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2031

Expected
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

July 12, 2022

Last Update Submit

May 31, 2024

Conditions

Breast CancerScreening

Keywords

Breast cancerDense breastRisk factorsUltrasonography

Outcome Measures

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

    from 3 months to 7 years after the GTC assessment

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

16164 women

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • currently pregnant or breast feeding in the preceding 6 months
  • Known distant metastasis from other primary cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 35617993BACKGROUND

  • 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.

    PMID: 34282967BACKGROUND

  • 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.

    PMID: 36749212BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Woo Kyung Moon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woo Kyung Moon, MD, PhD

CONTACT

+82220722584moonwk1963@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

November 1, 2022

Primary Completion

March 30, 2026

Study Completion (Estimated)

December 30, 2031

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)