Clinical trial · Observational
The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness
Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only
NCT02909426CI-TRIAL-00054323MUST-BEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Cancer | Invasive Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital mammography | Device | — | UNRESOLVED |
| Ultrasonography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women aged 40-59
- description
- 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.
- interventionNames
- Device: Ultrasonography
- Device: Digital mammography
Primary outcomes (1)
- measure
- Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
- timeFrame
- 1 year after the screening
- description
- rate of positive results of the screening among histologically proved breast cancer patients
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Interstitial injection * Women with history of any cancer
References
Publications (1)
- BACKGROUNDOhuchi 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 26547101