The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness

Ductal Carcinoma in Situ Clinical Trial

— MUST-BE  

Official title:

Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02909426
• Other study ID #: 1520200
• Status: Active, not recruiting
• Start date: May 2, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11880
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ
• Invasive Cancer

Intervention

Device:
• Ultrasonography
Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
• Digital mammography
Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital	Bucheon	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost-effectiveness of supplemental ultrasonography of the breast	Comparison of the cost for detecting one breast cancer patient by two groups.	1 year after the screening
Secondary	Cost-utility of supplemental ultrasonography of the breast	Measurement of the incremental cost-utility ratio, which is calculated by dividing the difference in costs by difference in the quality-adjusted life year (QALY).	1 year after the screening