UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032298 |
|---|---|
| Receipt number | R000036829 |
| Scientific Title | Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM) |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2018/04/18 09:44:56 |
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Basic information
Public title
Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Acronym
CD-CONFIRM
Scientific Title
Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Scientific Title:Acronym
CD-CONFIRM
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We developed a draft of color Doppler diagnostic criteria for breast masses by JABTS BC-04 study. In this study, we will study the usefulness of the color Doppler criteria. Furthermore, we will study the usefulness of elastography for breast masses in benign/malignant diagnosis. If possible, we will study about color Doppler diagnostic criteria for complex cystic and solid masses.
Basic objectives2
Others
Basic objectives -Others
Usefulness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Sensitivity, specificity and accuracy of the B-mode alone, and the combination of color Doppler and B-mode.
2. Examination of usefulness of each finding of the color Doppler ultrasound in benign/malignant diagnosis (univariate analysis and multivariate analysis).
Key secondary outcomes
1. Sensitivity, specificity and accuracy of the B-mode alone, and the combination of color Doppler, B-mode and elastography.
2. Impact of age factor on the sensitivity and/or specificity of the new diagnosis system
3. Reproducibility of evaluators
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Lesions recognized as a mass on breast ultrasonography (including complex cystic and solid masses)
2. Digital video clips of color Doppler method are available
3. Pathologically confirmed masses
4. Even masses without pathological confirmation can be registered as benign masses if it is confirmed that there was no change for more than one year on the B-mode ultrasound
Key exclusion criteria
1. Typical simple cyst
2. Lesions which received vacuum-assisted biopsy
3. Masses more than 5 cm in diameter
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Watanabe |
Organization
National Hospital Organization Sendai Medical Center
Division name
Breast Surgery
Zip code
Address
2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL
022-293-1111
tak@snh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Watanabe |
Organization
National Hospital Organization Sendai Medical Center
Division name
Breast Surgery
Zip code
Address
2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL
022-293-1111
Homepage URL
tak@snh.go.jp
Sponsor or person
Institute
The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
Institute
Department
Personal name
Funding Source
Organization
The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構 仙台医療センター
医療法人慶友会守谷慶友病院
吹田徳洲会病院
南大阪病院外科
公益財団法人東京都予防医学協会
兵庫県立がんセンター
糸島医師会病院
獨協医科大学病院
神戸市立西神戸医療センター
国立病院機構大阪医療センター
とくしまブレストケアクリニック
香川医療生活協同組合高松平和病院
社会医療法人博愛会相良病院
札幌ことに乳腺クリニック
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collected ultrasound images of the subjects will be evaluated by independent Centralized Image Interpretation Committee using the draft of color Doppler diagnostic criteria.
Management information
Registered date
| 2018 | Year | 04 | Month | 18 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036829
