Clinical trial NCT02909426: The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness
Official title: Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Cancer
Ductal Carcinoma in Situ
Keywords: Screening
Digital mammography
Ultrasonography
Sensitivity
Specificity
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2016-09-21
Enrollment: 11880
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 40-59 years at target population in National Cancer Screening Program

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.

Detailed description: The investigators will screen same consecutive participants using both methods; digital mammography plus supplemental ultrasonography (intervention arm) and digital mammography only (control arm) for 5 years. The investigators will collect follow-up information by assessment of screening records, questionnaire, and official cancer registry. The primary outcome will be sensitivity, specificity, recall rate, cancer detection rate and stage distribution at the end of first round of screening. The secondary outcome will be cost-effectiveness and cost-utility of digital mammography with ultrasonography versus digital mammography only for breast cancer screening. It is hoped that the results of this trial will provide guidance of effective breast cancer screening strategy to women aged 40-59, especially with dense breasts.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
timeFrame: 1 year after the screening
Secondary outcomes:
measure: Cost-effectiveness of supplemental ultrasonography of the breast
timeFrame: 1 year after the screening
measure: Cost-utility of supplemental ultrasonography of the breast
timeFrame: 1 year after the screening
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
state: Gyeonggi-do
Study officials:
affiliation: Soonchunhyang University Hospital
name: EUN HYE LEE, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.