NCT02909426

Brief Summary

Mammography screening has limited performance in young women or women with dense breasts although it is the only proven method for breast cancer screening that reduces the mortality. The investigators propose a multicenter trial of breast cancer screening to assess the effectiveness of supplemental ultrasonography for Korean women aged 40-59 years.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

May 2, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

4.7 years

First QC Date

September 5, 2016

Last Update Submit

October 5, 2021

Conditions

Invasive CancerDuctal Carcinoma in Situ

Keywords

ScreeningDigital mammographyUltrasonographySensitivitySpecificity

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only

    rate of positive results of the screening among histologically proved breast cancer patients

    1 year after the screening

Secondary Outcomes (2)

  • Cost-effectiveness of supplemental ultrasonography of the breast

    1 year after the screening

  • Cost-utility of supplemental ultrasonography of the breast

    1 year after the screening

Study Arms (1)

Women aged 40-59

Asymptomatic women aged 40-59 who participate in the National Cancer Screening Program in Korea and agreed with participating in this study will be the cohort. The participants' digital mammography and ultrasonography will be interpreted combinedly by radiologists who perform the screening sonography and the participants' digital mammography will be interpreted independently by other radiologists who do not perform the screening sonography.

Device: UltrasonographyDevice: Digital mammography

Interventions

UltrasonographyDEVICE

Radiologists' hand-held bilateral breast ultrasonography for each participant for one time

Women aged 40-59
Digital mammographyDEVICE

Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time

Women aged 40-59

Eligibility Criteria

Age40 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 40-59 years at target population in National Cancer Screening Program

You may qualify if:

  • Women aged 40-59 years
  • No history of any cancer
  • No breast mammography (and ultrasonography, in case of intervention arm) after the introduction of digital mammography

You may not qualify if:

  • Interstitial injection
  • Women with history of any cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soon Chun Hyang University Hospital

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Related Publications (1)

  • Ohuchi N, Suzuki A, Sobue T, Kawai M, Yamamoto S, Zheng YF, Shiono YN, Saito H, Kuriyama S, Tohno E, Endo T, Fukao A, Tsuji I, Yamaguchi T, Ohashi Y, Fukuda M, Ishida T; J-START investigator groups. Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for breast cancer in the Japan Strategic Anti-cancer Randomized Trial (J-START): a randomised controlled trial. Lancet. 2016 Jan 23;387(10016):341-348. doi: 10.1016/S0140-6736(15)00774-6. Epub 2015 Nov 5.

    PMID: 26547101BACKGROUND

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingHypersensitivity

Interventions

UltrasonographyMammography

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiography

Study Officials

  • EUN HYE LEE, MD, Ph.D

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Breast Imaging, Principal Investigator, Professor

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 21, 2016

Study Start

May 2, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2023

Last Updated

October 7, 2021

Record last verified: 2021-10

Locations

KR(1)