Invasive CancerMUST-BENCT02909426
The Mammography and Ultrasonography STudy for Breast Cancer Screening Effectiveness
An observational study of Invasive Cancer and Ductal Carcinoma in Situ, run by Soonchunhyang University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Cancer, Ductal Carcinoma in Situ
- What is being tested?
- Ultrasonography and Digital mammography
- Type of treatment
- Medical device
- How many people
- 11,880 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2016to 31 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 40-59 years at target population in National Cancer Screening Program
Who may be able to join
- 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
Who cannot join
- Interstitial injection
- Women with history of any cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soon Chun Hyang University Hospital
Bucheon-si, Gyeonggi-do, 420-767
About this study
Official title: Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only
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.
Read the 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.
- Conditions
- Invasive Cancer, Ductal Carcinoma in Situ
- Being tested
- Ultrasonography, Digital mammography
- Keywords
- Screening, Digital mammography, Ultrasonography, Sensitivity, Specificity
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasonography; Device: Digital mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after the screening
Secondary outcomes (2)
Cost-effectiveness of supplemental ultrasonography of the breast
Comparison of the cost for detecting one breast cancer patient by two groups.
Measured: 1 year after the screening
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).
Measured: 1 year after the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start2 May 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,880 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, EUN HYE LEE, Soonchunhyang University Hospital
- Investigators
- EUN HYE LEE, MD, Ph.D, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909426
- Sponsor's protocol ID
- 1520200
- Acronym
- MUST-BE
- Status last verified
- Oct 2021
- First submitted
- 5 Sep 2016
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26547101
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Breast Cancer Screening in Women Aged 40-59: Digital Mammography With Supplemental Breast Ultrasonography Versus Digital Mammography Only
- ClinicalTrials.gov ID
- NCT02909426
- Acronym / sponsor ID
- MUST-BE / 1520200
- Conditions
- Invasive Cancer, Ductal Carcinoma in Situ
- Keywords
- Screening, Digital mammography, Ultrasonography, Sensitivity, Specificity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,880 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 2 May 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 40-59 | – | Device: Ultrasonography, Device: Digital mammographyAsymptomatic 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. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 40-59 years at target population in National Cancer Screening Program
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Interstitial injection
- Women with history of any cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyRadiologists' hand-held bilateral breast ultrasonography for each participant for one time | Device | Women aged 40-59 |
| Digital mammographyFull-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time | Device | Women aged 40-59 |
Primary outcome
Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only
Time frame: 1 year after the screening
rate of positive results of the screening among histologically proved breast cancer patients
2 secondary outcomes
Cost-effectiveness of supplemental ultrasonography of the breast
Time frame: 1 year after the screening
Cost-utility of supplemental ultrasonography of the breast
Time frame: 1 year after the screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Background: PubMed 26547101Ohuchi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EUN HYE LEE, MD, Ph.D principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Cancer and Ductal Carcinoma in Situ, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of digital mammography with supplemental breast ultrasonography and digital mammography only (time frame: 1 year after the screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.