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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026289
Receipt No. R000030197
Scientific Title Multicenter study to evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Date of disclosure of the study information 2017/03/01
Last modified on 2018/03/31

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Basic information
Public title Multicenter study to evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Acronym FLOW-CEUS 01
Scientific Title Multicenter study to evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Scientific Title:Acronym FLOW-CEUS 01
Region
Japan

Condition
Condition breast cancer and breast benign lesion
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of contrast-enhanced pattern between benign and malignant breast lesions by contrast-enhanced ultrasonography
Basic objectives2 Others
Basic objectives -Others To create the evaluation criteria of the contrast-enhanced ultrasound pattern for differential diagnosis (benign vs malignant) of local breast lesions
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The concordance rate of the evaluation of the pattern on CEUS among the blind readers
Key secondary outcomes The sensitivity, specificity, accuracy and certainty factor of the CEUS and unenhanced ultrasound (B-mode)

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) A breast mass (lesion on interest) underwent CEUS.
2) Pathologically proved breast mass after CEUS.
3) A breast mass less than 3 cm in diameter by unenhanced ultrasound.
Key exclusion criteria 1)Patients who were underwent anticancer therapy, including chemotherapy or radiation therapy before breast CEUS.
2)Any other conditions that made the patient unsuitable for participation in this study according to each principal investigator or subinvestigator.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nakamura
Organization Nara Medical University
Division name Department of Surgery
Zip code
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Email takasi@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nakamura
Organization Nara Medical University
Division name Department of Surgery
Zip code
Address 840 Shijo-cho Kashihara Nara
TEL 0744-22-3051
Homepage URL
Email takasi@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization The Japan association of Breast and Thyroid Sonology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is being conducted as a research group of Japan Association of Breast and Thyroid Sonology.

Management information
Registered date
2017 Year 02 Month 24 Day
Last modified on
2018 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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