UMIN-CTR Clinical Trial

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

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

tak@snh.go.jp

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

Email

tak@snh.go.jp

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2018

Year

04

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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