UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026289 |
|---|---|
| Receipt number | 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 | 2022/08/30 22:20:28 |
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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 | Takashi |
| Middle name | |
| Last name | Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8522
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
takasi@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nakamura |
Organization
Nara Medical University
Division name
Department of Surgery
Zip code
634-8522
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
Homepage URL
takasi@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
Nara Medical University
Address
840 Shijo-cho Kashihara Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
222
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the delay in analyzing the results
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
| 2015 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030197
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
