UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study to confirm the usefulness of the color Doppler ultrasound diagnostic criteria for breast masses (CD-CONFIRM)
Title of the study (Brief title)	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	Takanori Watanabe
Organization	National Hospital Organization Sendai Medical Center
Division name	Breast Surgery
Address	2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL	022-293-1111
Email	tak@snh.go.jp

Public contact
Name of contact person	Takanori Watanabe
Organization	National Hospital Organization Sendai Medical Center
Division name	Breast Surgery
Address	2-8-8 Miyagino, Miyagino-ku, Sendai, Miyagi 983-8520, Japan
TEL	022-293-1111
Homepage URL
Email	tak@snh.go.jp

Sponsor
Institute	The Japan Society of Ultrasonics in Medicine, Japan Association of Breast and Thyroid Sonology
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036829